Fast acting ITCH relief cooling spray

Abstract

This disclosure provides fast acting itch relief and cooling sprays containing hydrocortisone, a cooling agent, such as sensate molecule (e.g. menthyl lactate), and a soothing agent (such as e.g., Aloe vera). The sprays of the disclosure can be used to relieve itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis. The disclosure also provides for methods of treating skin with cooling sprays as well as containers containing the spray.

Description

FAST ACTING ITCH RELIEF COOLING SPRAYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application 63 / 623,538 (filed on January 22, 2024) which is incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] This disclosure relates to a fast acting itch relief and cooling sprays containing hydrocortisone, Aloe vera, and a cooling agent. The disclosure also relates to using these sprays to relieve itch and cool areas of affected skin.BACKGROUND OF THE INVENTION

[0003] According to the Mayo Clinic, itchy skin is an irritating sensation that makes one want to scratch. It is also called pruritus. Often itchy skin is caused by dry skin and is more common in older adults due to skin becoming drier with age. Treatment of itchy skin focuses on removing the cause of the itch.

[0004] Common itch treatments involve locally applying a corticosteroid, such as e.g., hydrocortisone. Hydrocortisone can be applied as an ointment or in other forms. However, regardless of how hydrocortisone is applied, the hydrocortisone only provides a delayed itch relief. It does not provide an immediate cooling or soothing sensations to areas of itchy skin which are often warmer.

[0005] To improve the relief provided by hydrocortisones, hydrocortisone has been formulated as spray formulations. U.S. Patent No. 3,456,052 discloses aerosol compositions containing butoxymonoether of a polyoxyalkylene glycol. These compositions can contain a medicament such as thimerosal, bacitracin, benzocaine, lidocaine, hydrocortisone, neomycin sulfate, penicillin, tetracycline, polymixin B sulfate, and mixtures thereof. A private label is currently selling a 1% hydrocortisone spray that offers itch relief. However, these spray formulations, while providing itch relief, fail to provide cooling or soothing benefits.

[0006] What is needed is a localized treatment that allows for localized itch relief and that provides cooling and soothing benefits.SUMMARY OF THE INVENTION

[0007] Other features and advantages of the invention will be apparent from the detailed description and examples that follow.

[0008] The disclosure provides spray formulations containing hydrocortisone, a soothing agent (such as e.g, Aloe vera). and a cooling agent. The spray formulations can be used for localized itch relief and provide cooling and soothing benefits.

[0009] One embodiment of the disclosure is directed to a spray formulation containing hydrocortisone, Aloe vera, a cooling agent, and a propellant. In some embodiments, the spray formulation contains: from about 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of Aloe vera; and / or from about 0.3 to about 1.5 wt. % of the cooling agent.

[0010] Another embodiment of the disclosure is directed to hydrocortisone, a soothing agent, a cooling agent, and a propellant. In some embodiments, the spray formulation contains: from about 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of the soothing agent; and / or from about 0.3 to about 1.5 wt. % of the cooling agent. A variety of different soothing agents may be used. In some embodiments, the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0011] In one embodiment, the cooling agent is a sensate molecule. In another embodiment, the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof. In an alternate embodiment, the sensate molecule is menthyl lactate.

[0012] A variety of propellants may be used. In one embodiment, the propellant is selected from the group consisting of compressed air, compressed nitrogen, propane, n- butane, isobutane, dimethyl ether, carbon dioxide, nitrous oxide, hydrofl uoroalkanes and combinations thereof. In another embodiment, the propellant is isobutane. In another embodiment, the propellant is dimethyl ether. The spray formulation can contain from about 25 to about 55 wt. % of the propellant.

[0013] The spray formulation can also contain an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant. In some embodiments, the spray formulations can also contain citric acid. In one embodiment, the formulation contains avenanthramides, such as, for example, an oat extract containing avenanthramides, e.g., from about 0. 1 to about 3 wt. % of the oat extract.

[0014] In certain embodiments, the spray formulation further contains ethyl alcohol, PEG-8, glycerin, methyl gluceth-20, ethoxy diglycol, and / or hydroxypropyl cellulose. Inother embodiments, the spray formulation further contains ethyl alcohol, PEG-8, glycerin, methyl gluceth-20, ethoxy diglycol, hydroxypropyl cellulose, and / or citric acid. In one embodiment, the spray formulation contains: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxy diglycol; ethyl alcohol; methyl gluceth-20; and hydroxypropyl cellulose. In another embodiment, the spray formulation contains: from 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about 1.5 wt. % of menthyl lactate; from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1.5 wt. % of PEG-8; glycerin; from about 0.3 to about 1.5 wt. % of ethoxydiglycol; from about 40 to about 75 wt. % of ethyl alcohol; from about 0.3 to about 1.5 wt. % of methyl gluceth-20; and from about 0.3 to about 0.9 wt. % of hydroxypropyl cellulose. This formulation can also contain propellants isobutane or dimethyl ether. In certain embodiments, the formulation contains from about 25 to about 55 wt. % of the propellant.

[0015] The disclosure also includes a container containing the spray formulations. In addition, the disclosure includes kits containing the spray formulations and instructions for use.

[0016] Another embodiment of the disclosure is a method of treating the skin of a patient in need thereof containing applying the spray formulations to the skin of the patient. In certain embodiments, the treatment includes cooling the skin and relieving an itch.

[0017] Yet another embodiment of the disclosure is a localized method of cooling and relieving skin itch including topically applying the spray formulations to an area of itchy skin. In some embodiments, the skin itch is associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

[0018] In certain embodiments, the disclosure is directed to use of the spray formulations in the manufacture of a medicament for treating pruritus. Alternatively, the disclosure is directed to use of the spray formulations for treating pruritus.

[0019] Another embodiment is a base formulation containing hydrocortisone. Aloe vera, and a cooling agent, whereby the base formulation is suitable for application to the skin of a patient as a spray upon addition of a propellant. The base formulation may lack a propellant (such as e.g., isobutane or dimethyl ether).

[0020] A further embodiment is a base formulation containing hydrocortisone, a soothing agent, and a cooling agent, whereby the base formulation is suitable for application to the skin of a patient as a spray upon addition of a propellant. In some embodiments, thesoothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof. In other embodiments, the soothing agent is Aloe vera.

[0021] In one embodiment, the base formulation contains from about 0.1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of menthyl lactate.

[0022] In an alternate embodiment, the cooling agent in the base formulation is a sensate molecule. The sensate molecule may be selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof.

[0023] In some embodiments, the base formulation contains citric acid. In other embodiments, the base formulation contains avenanthramides, such as for example an oat extract containing avenanthramides.

[0024] In another embodiment, the base formulation also contains an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant. In yet another embodiment, the base formulation contains: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxy diglycol; ethyl alcohol; methyl gluceth-20; and hydroxypropyl cellulose. In an alternate embodiment, the base formulation contains: hydrocortisone: Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxy diglycol; ethyl alcohol; methyl gluceth-20; hydroxypropyl cellulose, and optionally citric acid.

[0025] In one embodiment, the base formulation contains: from about 0. 1 to about 5 wt. % of hydrocortisone; from about 0.05 to about 0.35 wt. % of Aloe vera; from about 0.5 to about 2 wt. % of menthyl lactate; from about 0.5 to about 2 wt. % of oat extract; from about 0.5 to about 2 wt. % of PEG-8; glycerin; from about 0.5 to about 2 wt. % of ethoxydi glycol; from about 75 to about 95 wt. % of ethyl alcohol; from about 0.5 to about 2 wt. % of methyl gluceth-20; and from about 0.5 to about 2 wt. % of hydroxy propyl cellulose.

[0026] Yet another embodiment of the disclosure is a container (e.g., a plastic or metal container) containing the base formulation. The disclosure also includes a method of generating a spray formulation, which includes mixing a base formulation with a propellant to thereby generate the spray formulation. In some embodiments, the propellant is isobutane or dimethyl ether. The method can also include the steps of packaging the spray formulation in a container, such as e.g., a plastic container or a metal container.

[0027] Another embodiment is a method of generating a spray formulation including: mixing hydrocortisone. Aloe vera, a cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose to generate a base formulation; mixing the base formulation with a propellant to generate a spray formulation; and packaging the spray formulation in a container. In some embodiments of the method, the cooling agent is a sensate molecule. In certain embodiments, the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethyl amido oxalate, vanillyl butyl ether, and combinations thereof. In another embodiment the sensate molecule is menthyl lactate. In some embodiments, the propellant is isobutane or dimethyl ether. In other embodiments, the method includes mixing hydrocortisone. Aloe vera, a cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and citric acid to generate a base formulation.DETAILED DESCRIPTION

[0028] This disclosure provides itch relief and cooling sprays containing hydrocortisone, a soothing agent (such as e.g., Aloe vera), and a cooling agent (such as a sensate molecule (e.g., menthyl lactate)), methods of making the sprays, and methods of using the sprays. In certain embodiments, the sprays contain hydrocortisone, _Aloe vera, and a cooling agent (such as a sensate molecule (e.g.. menthyl lactate)). These sprays allow for localized itch relief and provide cooling and soothing benefits.

[0029] The itch relief and cool sprays provide fast cooling relief to itchy skin from rashes, irritation, insect bites, poison ivy, and sumac. The sprays target itch at its source for quick cooling relief and comfort.

[0030] In certain embodiments and without being bound by theory, the sprays of the disclosure offer immediate cooling and soothing benefits due to formulations containing menthyl lactate as a cooling agent and aloe for skin soothing benefits. The spray experience is superior when compared to the existing hydrocortisone containing spray on the market.

[0031] In yet another embodiment and again without being bound by theory, the spray formulations of the disclosure provide several unique benefits including: fast acting itch relief (with soothing Aloe); quick dry ing, no rub, no run, no mess application; and fine mist spray with cooling feel; spray upside down upside down. The spray formulation are also quick and easy to use. The cooling effect provides itch relief which conventional topical ointments lack. The spray formulations provide for a cleaner application to the skin, whichavoids getting medicine on a user’s hands as well as clothing and avoids having to clean them afterwards.

[0032] In certain embodiments, the spray formulations provide fast cooling itch relief to relieve itch and discomfort associated with: rashes caused by insect bites, poison ivy, poison oak, or poison sumac; eczema; psoriasis; minor skin irritations; soaps / detergents; and cosmetics.

[0033] The general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as defined in the appended claims. Other aspects of the present invention w ill be apparent to those skilled in the art in view of the detailed description of the invention as provided herein.

[0034] For clarity of disclosure, and not by way of limitation, the detailed description of the invention is divided into subsections that describe or illustrate certain features, embodiments, or applications of the present invention.Definitions

[0035] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods, and materials are now described.

[0036] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0037] It is noted that, as used herein and in the appended claims, the singular forms ’‘a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0038] Each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

[0039] As used herein, the term “about” when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ± 20% or ± 10%, more preferably ± 5%, even more preferably ± 1%, and still more preferably ± 0.1% from the specified value, as such variations are appropriate to perform the disclosed methods.

[0040] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0041] As used herein, the terms “comprising,” “including,” “containing” and “characterized by” are exchangeable, inclusive, open-ended and do not exclude additional, unrecited elements or method steps. Any recitation herein of the term “comprising,” “including,” or “containing,” particularly in a description of components of a composition or in a description of elements of a device, is understood to encompass those compositions and methods consisting essentially of and consisting of the recited components or elements.

[0042] As used herein, the term “consisting of’ excludes any element, step, or ingredient not specified in the claim element.

[0043] Before certain embodiments are described in greater detail, it is to be understood that this invention is not limited to certain embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing certain embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0044] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the statedrange. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0045] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0046] A “subject” or “patient,” as used therein, may be a human or non-human mammal. Non-human mammals include, for example, livestock and pets, such as ovine, bovine, porcine, canine, feline, and marine mammals. Preferably, the subject is human.

[0047] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0048] As used herein, and as well-understood in the art, “treatment” is an approach for obtaining beneficial or desired results, including clinical results. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, alleviation or amelioration of one or more symptoms, diminishment of extent of disease, stabilized (z.e., not worsening) state of disease, preventing spread of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable.Spray Formulations

[0049] One aspect of the disclosure is directed to spray formulations, which provide itch relief and cooling. These spray formulations contain hydrocortisone, Aloe vera, a cooling agent, and a propellant. In other embodiments, these spray formulations contain hydrocortisone, a soothing agent (such as e.g., Aloe vera), a cooling agent, and a propellant.

[0050] A variety of soothing agents can be used in the formulations. In one embodiment, the cooling agent is Aloe vera. In other embodiments, the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides.calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0051] A variety of cooling agents can be used in the formulations. In one embodiment, the cooling agent is a sensate molecule. In certain embodiments, the cooling agent is a sensate molecule selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof.

[0052] In one embodiment, the cooling agent is menthyl lactate. Accordingly, in certain embodiments, the spray formulations contain hydrocortisone, Aloe vera, menthyl lactate, and a propellant.

[0053] Examples of suitable propellant include, but are not limited to, compressed air, compressed nitrogen, propane, n-butane, isobutane, dimethyl ether, carbon dioxide, nitrous oxide, hydrofluoroalkanes and combinations thereof. In certain embodiments, the propellant is isobutane or dimethyl ether. In further embodiments, the propellant is isobutane, dimethyl ether, or a mixture thereof. In one embodiment, the propellant is isobutane. In another embodiment, the propellant is dimethyl ether.

[0054] A variety of other components may be added to the formulations. In certain embodiments, the spray formulations also contain an anti-inflammatory' agent, an antioxidant agent, a moisturizing agent, and / or a humectant. In some embodiments, the spray formulations also contain avenanthramides, PEG-8, glycerin, ethoxy diglycol (2-(2- Ethoxyethoxy)ethanol), ethyl alcohol, methyl gluceth-20 (a-Hydro-(D-hydroxypoly(oxy-l,2- ethanediyl) ether with methyl |3-D-glucopyranoside (4: 1) (CAS 68239-42-9)), and / or hydroxypropyl cellulose.

[0055] In certain embodiments, the avenanthramides are provided in an oat extract containing avenanthramides. As used herein, the term “oat extract” is defined as “oat extract containing avenanthramides.” Thus, in some embodiments, the spray formulations also contain oat extract, PEG-8, glycerin, ethoxy diglycol (2-(2-Ethoxyethoxy)ethanol), ethyl alcohol, methyl gluceth-20 (a-Hydro-co-hydroxypoly(oxy-1.2-ethanediyl) ether with methyl [3-D-glucopyranoside (4: 1) (CAS 68239-42-9)), and / or hydroxypropyl cellulose.

[0056] Various amounts of avenanthramides can be used in the spray formulations. In certain embodiments, the spray formulations contain from about 25 to about 150 ppm, alternatively from about 30 to about 120 ppm, alternatively from about 40 to about 100 ppm of avenanthramides.

[0057] In certain embodiments, the ethyl alcohol is SD Alcohol 40-B 200 proof. In other embodiments, the hydroxypropyl cellulose has a viscosity range of 200-600 cps.

[0058] In one embodiment, the spray formulation contains hydrocortisone, a soothing agent (such as e.g., Aloe vera), menthyl lactate, avenanthramides (such as e.g., oat extract containing avenanthramides), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and a propellant. In another embodiment, the spray formulation contains hydrocortisone, a soothing agent (such as e.g.. Aloe vera). menthyl lactate, avenanthramides (such as e.g., oat extract containing avenanthramides), PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and isobutane. In yet another embodiment, the spray formulation contains hydrocortisone, a soothing agent (such as e.g., Aloe vera), menthyl lactate, avenanthramides (such as e.g., oat extract containing avenanthramides), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and dimethyl ether.

[0059] In an alternate embodiment, the spray formulation only contains hydrocortisone, a soothing agent (such as e.g., Aloe vera), menthyl lactate, avenanthramides (such as e.g., oat extract containing avenanthramides), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and isobutane. In yet another embodiment, the spray formulation only contains hydrocortisone, a soothing agent (such as e.g., Aloe vera), menthyl lactate, avenanthramides (such as e.g., oat extract containing avenanthramides), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and dimethyl ether.

[0060] In one embodiment, the spray formulation contains hydrocortisone, Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth- 20, hydroxypropyl cellulose, and a propellant. In another embodiment, the spray formulation contains hydrocortisone. Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and isobutane. In yet another embodiment, the spray formulation contains hydrocortisone, Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20. hydroxypropyl cellulose, and dimethyl ether.

[0061] In an alternate embodiment, the spray formulation only contains hydrocortisone. Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and isobutane. In yet another embodiment, the spray formulation only contains hydrocortisone. Aloe vera, menthyl lactate, oat extract,PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and dimethyl ether.

[0062] In certain embodiments, the spray formulations contain from about 0. 1 to about 5.0 wt. %, alternatively, from about 0.1 to about 1 wt. %, alternatively from about 0.5 to about 2.5 wt. %, alternatively from about 0.3 to about 0.9 wt. %, alternatively from about 0.35 to about 0.85 wt. %. alternatively from about 0.4 to about 0.8 wt., alternatively from about 0.05 to about 3 wt. %, alternatively from about 0.05 to about 2 wt. %. alternatively from about 0. 1 to about 1.5 wt. % of hydrocortisone.

[0063] In some embodiments, the spray formulations contain from about 0.01 to about 1 wt. %, alternatively from about 0.05 to about 0.25 wt. %, alternatively from about 0.08 to about 0.02 wt. %. alternatively from about 0.01 to about 0.016 wt. % of Aloe vera. In alternate embodiments, the spray formulations contain from about 0.01 to about 1 wt. %, alternatively from about 0.05 to about 0.25 wt. %, alternatively from about 0.08 to about 0.02 wt. %, alternatively from about 0.01 to about 0.016 wt. % of a soothing agent selected from Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0064] Various amounts of cooling agents may be used in the formulations. For example, the formulation may contain from about 0.1 to about 3 wt. %, alternatively from about 0.3 to about 1.5 wt. %, alternatively from about 0.35 to about 1 wt. %, alternatively from about 0.4 to about 0.9 wt. % of the cooling agent. In certain embodiments, the formulations contain from about 0.1 to about 3 wt. %, alternatively from about 0.3 to about 1.5 wt. %, alternatively from about 0.35 to about 1 wt. %, alternatively from about 0.4 to about 0.9 wt. % of the sensate molecule (e.g., menthyl lactate) may be used in the formulations.

[0065] In certain embodiments, the spray formulation contain from about 25 to about 55 wt. %, alternatively from about 30 to 50 wt. %, alternatively from 35-45 wt. % of the propellant.

[0066] In one embodiment, the spray formulation contains from about 25 to about 55 wt. %, alternatively from about 30 to 50 wt. %, alternatively from 35-45 wt. % of isobutane.

[0067] Various amounts of methyl gluceth-20. PEG-8, glycerin, oat extract, and ethoxydiglycol may be used. Exemplary suitable amounts for methyl gluceth-20, PEG-8, glycerin, oat extract, and / or ethoxydiglycol can be used in the spray formulations are from about 0.1 to about 3 wt. %, alternatively from about 0.3 to about 1.5 wt. %, alternatively from about 0.35 to about 1 wt. %, alternatively from about 0.4 to about 0.9 wt. %.

[0068] In other embodiments, the spray formulations contain from about 40 to about 75 wt. %, alternatively from about 45 to about 70 wt. %, alternatively from about 50 to about 60 wt. % of ethyl alcohol.

[0069] In further embodiments, the spray formulations contain from about 0.3 to about 0.9 wt. %, alternatively from about 0.35 to about 0.85 wt. %, alternatively from about 0.4 to about 0.8 wt. % of hydroxy propyl cellulose.

[0070] In additional embodiments, the spray formulations can also contain citric acid. In some embodiments, the spray formulations contain less than 0.09% wt., alternatively from about 0.01 to about 0.08% wt., alternatively from about 0.01 to about 0.06% wt., alternatively from about 0.01 to about 0.05% wt. of citric acid. In other embodiments, the spray formulations do not contain citric acid.

[0071] In certain embodiments, the spray formulations contain hydrocortisone, Aloe vera, and a cooling agent as well as optionally an oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20. hydroxypropyl cellulose, and / or a propellant in any of the amounts listed above. In certain embodiments, the spray formulations contain hydrocortisone. Aloe vera, and a cooling agent as well as optionally an oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, a propellant and / or citric acid in any of the amounts listed above.

[0072] In some embodiments, the spray formulations contain: from 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about 1 .5 wt. % of a sensate molecule (e.g, menthyl lactate); and a propellant. The formulations can also further contain: from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1.5 wt. % of PEG-8; glycerin: from about 0.3 to about 1.5 wt. % of ethoxy diglycol: from about 40 to about 75 wt. % of ethyl alcohol: from about 0.3 to about1.5 wt. % of methyl gluceth-20; and / or from about 0.3 to about 0.9 wt. % of hydroxypropyl cellulose.

[0073] In one embodiment, the spray formulations contain: from 0. 1 to about 5.0 wt. % of hydrocortisone: from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about1.5 wt. % of menthyl lactate: from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1.5 wt. % of PEG-8; glycerin; from about 0.3 to about 1.5 wt. % of ethoxy di glycol; from about 40 to about 75 wt. % of ethyl alcohol; from about 0.3 to about1.5 wt. % of methyl gluceth-20; and from about 0.3 to about 0.9 wt. % of hydroxypropyl cellulose. The propellant is isobutane or dimethyl ether. The spray formulations can contain from about 25 to about 55 wt. % of the propellant.

[0074] Examples of suitable ranges of embodiments of spray formulations of the disclosure are shown in the Tables below. Each of the amounts listed for a component in the embodiments shown below may be combined. For example, any of the amounts of hydrocortisone, Aloe vera, cooling agent, oat extract, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and / or propellant (isobutane or dimethyl ether) in Embodiment A may be combined with any of the amounts of hydrocortisone. Aloe vera. cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and / or propellant (isobutane or dimethyl ether) in Embodiments B and / or C.

[0075] Any of the embodiments of the spray formulations shown in the Tables above can in certain embodiments be further supplemented with citric acid. For example, the spray formulations may be supplemented with less than 0.09% wt, alternatively from about 0.01 to about 0.08% wt., alternatively from about 0.01 to about 0.06% wt., alternatively from about 0.01 to about 0.05% wt. of citric acid.

[0076] In certain embodiments, the spray formulations are formulated to be applied to the skin of a patient (z. e. , topical application), such as e.g., a human.

[0077] The disclosure also includes containers (such as e.g., an aerosol container) containing the spray formulations of the disclosure. In certain embodiment, the container is a plastic container. In other embodiments, the container is a metal container. In one embodiment, the propellant is compressed air, nitrogen or another suitable gas, and the container is a bag-on-valve. The disclosure also includes kits containing a spray formulation of the disclosure and instructions for use.

[0078] The disclosure also includes the base formulations, which are the spray formulations discussed above excluding the propellant. In one embodiment, the baseformulation includes hydrocortisone. Aloe vera, and a cooling agent. The base formulation lacks a propellant (e.g. isobutane or dimethyl ether).

[0079] In one embodiment, the base formulation includes hydrocortisone, a soothing agent, and a cooling agent. The base formulation lacks a propellant e.g., isobutane or dimethyl ether). The soothing agent can be is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil. bisabolol, and combinations thereof.

[0080] The base formulations are suitable for topical application to the skin of a patient, e.g., a human. In certain embodiments, the base formulations are suitable for topical application to the skin of a patient as a spray upon the addition of a propellant (e.g, isobutane or dimethyl ether).

[0081] In some embodiments, the cooling agent is a sensate molecule. In certain embodiments, the cooling agent is a sensate molecule selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl buh l ether, and combinations thereof. In one embodiment, the cooling agent is menthyl lactate. Accordingly, in certain embodiments, the base formulations contain hydrocortisone, Aloe vera, and menthyl lactate.

[0082] A variety of other components may be added to the base formulations. In certain embodiments, the spray formulations also contain an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant. In some embodiments, the base formulations also contain oat extract, PEG-8, glycerin, ethoxy diglycol (2-(2- Ethoxyethoxy)ethanol), ethyl alcohol, methyl gluceth-20 (a-Hydro-co-hydroxypoly(oxy-l,2- ethanediyl) ether with methyl 0-D-glucopyranoside (4: 1) (CAS 68239-42-9)), and / or hydroxypropyl cellulose. In some embodiments, the base formulations also contain avenanthramides, PEG-8, glycerin, ethoxydiglycol (2-(2-Ethoxyethoxy)ethanol), ethyl alcohol, methyl gluceth-20 (a-Hydro-co-hydroxypoly(oxy-l,2-ethanediyl) ether with methyl 0-D-glucopyranoside (4: 1) (CAS 68239-42-9)), and / or hydroxy propyl cellulose.

[0083] In one embodiment, the base formulation contains hydrocortisone, Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth- 20, and hydroxypropyl cellulose. In an alternate embodiment, the base formulation only contains hydrocortisone, Aloe vera, menthyl lactate, oat extract, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose. In another embodiment, the base formulation contains hydrocortisone, Aloe vera, and menthyl lactate and at least one additional component selected from the group consisting of oat extract,PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and combinations thereof.

[0084] In an alternate embodiment, the base formulation contains hydrocortisone, a soothing agent (e.g., Aloe vera, hyaluronic acid, coconut oil, shea butter, and / or ceramides), menthyl lactate, avenanthramides (e.g., oat extract), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose. In an alternate embodiment, the base formulation only contains hydrocortisone, a soothing agent (e.g.. Aloe vera, hyaluronic acid, coconut oil, shea butter, and / or ceramides), menthyl lactate, avenanthramides (e.g., oat extract), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose. In another embodiment, the base formulation contains hydrocortisone, a soothing agent (e.g., Aloe vera, hyaluronic acid, coconut oil, shea butter, and / or ceramides), and menthyl lactate and at least one additional component selected from the group consisting of avenanthramides (e.g., oat extract), PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and combinations thereof.

[0085] In certain embodiments, the ethyl alcohol is SD Alcohol 40-B 200 proof. In other embodiments, the hydroxy propyl cellulose has a viscosity range of 200-600 cps.

[0086] In some embodiments, the base formulations contain from about 0. 1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of the cooling agent. In other embodiments, the base formulations contain from about 0. 1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of menthyl lactate.

[0087] In one embodiment, the base formulation contains: from about 0. 1 to about 5 wt. % of hydrocortisone; from about 0.05 to about 0.35 wt. % of Aloe vera; from about 0.5 to about 2 wt. % of the cooling agent (e.g, menthyl lactate); from about 0.5 to about 2 wt. % of oat extract; from about 0.5 to about 2 wt. % of PEG-8; glycerin; from about 0.5 to about 2 wt. % of ethoxy diglycol; from about 75 to about 95 wt. % of ethyl alcohol; from about 0.5 to about 2 wt. % of methyl gluceth-20; and from about 0.5 to about 2 wt. % of hydroxypropyl cellulose.

[0088] In another embodiment, the base formulation contains from about 0.5 to about 2 wt. %, alternatively from about 0.5 to about 1.5 wt. %, alternatively from about 0.8 to about 1.2 wt. %, alternatively from about 0.1 to about 5 wt. %, alternatively from about 0.1 to about 1 wt. %, alternatively from about 0.5 to about 2.5 wt.% of hydrocortisone.

[0089] In yet another embodiment, the base formulation contains from about 0.05 to about 0.35 wt. %. alternatively from about 0. 1 to about 0.3 wt. %. alternatively from about 0. 15 to about 0.25 wt. % of a soothing agent (e.g., Aloe vera, hyaluronic acid, coconut oil, shea butter, and / or ceramides). In an alternate embodiment, the base formulation contains from about 0.05 to about 0.35 wt. %, alternatively from about 0.1 to about 0.3 w . %, alternatively from about 0. 15 to about 0.25 wt. % of Aloe vera.

[0090] In a further embodiment, the base formulation contains from about 0.5 to about 2 wt. %, alternatively from about 0.5 to about 1.5 wt. %, alternatively 0.8 to about 1.2 wt. % of a cooling agent. In some embodiments, the base formulation contains from about 0.5 to about 2 wt. %, alternatively from about 0.5 to about 1.5 wt. %, alternatively 0.8 to about 1.2 wt. % of a sensate molecule. In alternate embodiments, the base formulation contains from about 0.5 to about 2 wt. %, alternatively from about 0.5 to about 1.5 wt. %, alternatively 0.8 to about 1.2 wt. % of menthyl lactate.

[0091] In additional embodiments, the base formulation contains from about 75 to about 95 wt. %, alternatively from about 80 to about 97 wt. %, alternatively from about 85 to about 95 wt. % of ethyl alcohol.

[0092] Various amounts of methyl gluceth-20, PEG-8, glycerin, oat extract, and ethoxydiglycol may be used. Exemplary' suitable amounts for methyl gluceth-20, PEG-8, glycerin, oat extract, and / or ethoxydiglycol can be used in the base formulations are from about 0.05 to about 0.2 wt. %, alternatively 0.05 to about 0. 15 wt. %, alternatively 0.08 to about 0.12 wt. %.

[0093] In certain embodiments of the disclosure, base formulations can also contain citric acid. In some embodiments, the base formulations contain less than 0.1% wt., alternatively from about 0.01 to about 0.1% wt.. alternatively from about 0.05 to about 0.1%, alternatively from about 0.02 to about 0.9% wt. of citric acid. In other embodiments, the base formulations lack citric acid.

[0094] Various amounts of avenanthramides can be used in the base formulations. In certain embodiments, the base formulations contain from about 25 to about 150 ppm. alternatively from about 30 to about 120 ppm. alternatively from about 40 to about 100 ppm of avenanthramides.

[0095] In certain embodiments, the base formulations contain hydrocortisone, Aloe vera, and a cooling agents as well as optionally an oat extract. PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20. and / or hydroxypropyl cellulose in any of the amounts listed above. In other embodiments, the base formulations contain hydrocortisone, Aloevera, and a cooling agents as well as optionally an oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and / or citric acid in any of the amounts listed above.

[0096] Examples of suitable ranges of embodiments of base formulations of the disclosure are shown in the Tables below. Each of the amounts listed for a component in the embodiments shown below may be combined. For example, any of the amounts of hydrocortisone. Aloe vera. cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and / or hydroxypropyl cellulose in Embodiment D may be combined with any of the amounts of hydrocortisone, Aloe vera, cooling, oat extract, PEG- 8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and / or hydroxy propyl cellulose in Embodiments E and / or F.Embodiments of Base FormulationsEmbodiments of Base FormulationsEmbodiments of Base Formulations

[0097] Any of the embodiments of the base formulations shown in the Tables above can in certain embodiments be further supplemented with citric acid. For example, the base formulations may be supplemented with less than 0. 1% wt., alternatively from about 0.01 to about 0.1% wt., alternatively from about 0.05 to about 0.1%, alternatively from about 0.02 to about 0.9% wt. of citric acid.Methods of Generating the Spray Formulations

[0098] Another aspect for the disclosure is directed to methods of generating the spray formulation. In one embodiment, the methods include mixing individual components of the base formulation to generate the base formulation. In another embodiment, the methods include mixing the base formulations with the propellant (dimethyl ether or isobutane). In one embodiment, the methods include mixing the base formulations with dimethyl ether. In another embodiment, the methods include mixing the base formulations with isobutane. In certain embodiments, the methods also include packaging the spray formulations in an aerosol container.

[0099] In one embodiment, the method of generating the spray formulation includes mixing a base formulation as described herein with a propellant to thereby generate the spray formulation. The resultant spray formulation may be packaged in a container.

[0100] One embodiment of the disclosure is a method of generating a spray formulation, which include the steps of: mixing hydrocortisone, a soothing agent, a cooling agent, avenanthramides, PEG-8, glycerin, ethoxydiglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose to generate a base formulation; mixing the base formulation with a propellant to generate a spray formulation; and packaging the spray formulation in a container. In certain embodiments, the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof. In some embodiments, the soothing agent is Aloe vera.

[0101] In other embodiments, the cooling agent is a sensate molecule. In further embodiments, the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof. In some embodiments, the sensate molecule is menthyl lactate.

[0102] In certain embodiments, the avenanthramides are provided as an oat extract containing avenanthramides.

[0103] A variety of containers may be used in the methods. In one embodiment, the container is a plastic container, a metal container, or a bag-on-valve.

[0104] In certain the propellant is isobutane or dimethyl ether.

[0105] In some embodiments, the method includes mixing hydrocortisone, Aloe vera, a cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth- 20, hydroxypropyl cellulose, and citric acid to generate a base formulation.

[0106] Accordingly, the disclosure also includes containers containing the base formulations of the disclosure. The disclosure also includes kits containing a base formulation of the disclosure and instructions for mixing the solutions with a propellant.Methods of Treatment

[0107] Another embodiment of the disclosure is directed to methods of treating the skin of a patient in need thereof by applying the spray formulations of the disclosure to the skin. In certain embodiments, spray formulations are applied to areas of the skin that are itchy, e.g., pruritus.

[0108] In some embodiments, the disclosure provides for use of the spray formulation in the manufacture of a medicament for treating pruritus.

[0109] In certain embodiments, the spray formulations are used to relief itch associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

[0110] In certain embodiments, the methods provide for fast cooling relief to itchy skin from rashes, irritation, insect bites, poison ivy, and sumac.[OHl] One embodiment of the disclosure is a method of treating skin of a patient in need thereof comprising applying a spray formulation as disclosed herein to the skin of the patient. In certain embodiments, the applying includes spraying spray formulation onto the skin. In some embodiments, the treatment includes cooling the skin and relieving an itch.

[0112] Another embodiment of the disclosure is a localized method of cooling and relieving skin itch which includes applying the spray formulation as disclose herein to an area of itchy skin. In certain embodiments, the spray formulations are applied to localized area determined by the placement of a container containing the spray formulation. In certain embodiments, the skin itch is associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

[0113] Without further description, it is believed that one of ordinary skill in the art can, using the preceding description and the following illustrative examples, make and utilize the present invention and practice the claimed methods. The following working examples, therefore, specifically point out the preferred embodiments of the present invention, and are not to be construed as limiting in any way the remainder of the disclosure.EMBODIMENTS

[0114] The invention also provides the following non-limiting embodiments.

[0115] Embodiment 1 is a spray formulation comprising hydrocortisone, a soothing agent, a cooling agent, and a propellant.

[0116] Embodiment 2 is the spray formulation of embodiment 1, wherein the spray formulation comprises from about 0. 1 to about 5.0 wt. % of hydrocortisone.

[0117] Embodiment 3 is the spray formulation of embodiments 1 or 2, wherein the formulation comprises from about 0.05 to about 0.25 wt. % of the soothing agent.

[0118] Embodiment 4 is the spray formulation of any one of embodiments 1 to 3, wherein the formulation comprises from about 0.3 to about 1.5 wt. % of the cooling agent.

[0119] Embodiment 5 is the spray formulation of any one of embodiments 1 to 4, wherein the cooling agent is a sensate molecule.

[0120] Embodiment 6 is the spray formulation of embodiment 5, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl but l ether, and combinations thereof.

[0121] Embodiment 7 is the spray formulation of embodiment 5, wherein the sensate molecule is menthyl lactate.

[0122] Embodiment 8 is the spray formulation of any one of embodiments 1 to 7, wherein the propellant is selected from the group consisting of compressed air, compressed nitrogen, propane, n-butane, isobutane, dimethyl ether, carbon dioxide, nitrous oxide, hydrofluoroalkanes and combinations thereof.

[0123] Embodiment 9 is the spray formulation of any one of embodiments 1 to 8, wherein the propellant is isobutane.

[0124] Embodiment 10 is the spray formulation of any one of embodiments 1 to 8, wherein the propellant is dimethyl ether.

[0125] Embodiment 11 is the spray formulation of any one of embodiments 1 to 10, wherein the formulation comprises from about 25 to about 55 wt. % of the propellant.

[0126] Embodiment 12 is the spray formulation of any one of embodiments 1 to 11, wherein the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0127] Embodiment 13 is the spray formulation of embodiment 12, wherein the soothing agent is Aloe vera.

[0128] Embodiment 14 is the spray formulation of any one of embodiments 1 to 13, wherein the formulation further comprises an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant.

[0129] Embodiment 15 is the spray formulation of any one of embodiments 1 to 14, wherein the formulation further comprises avenanthramides.

[0130] Embodiment 16 is the spray formulation of embodiment 15, wherein the formulation comprises an oat extract containing avenanthramides.

[0131] Embodiment 17 is the spray formulation of embodiment 16, wherein the formulation comprises from about 0. 1 to about 3 wt. % of the oat extract.

[0132] Embodiment 18 is the spray formulation of any one of embodiments 1 to 17, wherein the formulation further comprises ethyl alcohol, PEG-8, glycerin, methyl gluceth- 20, ethoxy diglycol, hydroxypropyl cellulose and / or citric acid.

[0133] Embodiment 19 is the spray formulation of any one of embodiments 1 to 18 comprising: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxy diglycol; ethyl alcohol; methyl gluceth-20; and hydroxypropyl cellulose.

[0134] Embodiment 20 is the spray formulation of embodiment 19 comprising: from 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about 1.5 wt. % of menthyl lactate; from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1.5 wt. % of PEG-8; glycerin; from about 0.3 to about 1.5 wt. % of ethoxydiglycol; from about 40 to about 75 wt. % of ethyl alcohol; from about 0.3 to about 1.5 wt. % of methyl gluceth-20; and from about 0.3 to about 0.9 wt. % of hydroxypropyl cellulose.

[0135] Embodiment 21 is the spray formulation of embodiments 19 or 20 further comprising propellants isobutane or dimethyl ether.

[0136] Embodiment 22 is the spray formulation of embodiment 21 comprising from about 25 to about 55 wt. % of the propellant.

[0137] Embodiment 23 is a container comprising the spray formulation of any one of embodiments 1 to 22.

[0138] Embodiment 24 is a kit comprising the spray formulation of any one of embodiments 1 to 22 and instructions for use.3

[0139] Embodiment 25 is a bag-on valve filled with the spray formulation of any one of embodiments 1 to 22.

[0140] Embodiment 26 is a method of treating skin of a patient in need thereof comprising applying the spray formulation of any one of embodiments 1 to 22 to the skin of the patient.

[0141] Embodiment 27 is the method of embodiment 26, wherein the treating comprises cooling the skin and relieving an itch.

[0142] Embodiment 28 is a localized method of cooling and relieving skin itch comprising topically applying the spray formulation of any one of embodiments 1 to 22 to an area of itchy skin.

[0143] Embodiment 29 is the method of embodiment 28, wherein the skin itch is associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

[0144] Embodiment 30 is Use of the spray formulation of any one of embodiments 1 to 22 in the manufacture of a medicament for treating pruritus.

[0145] Embodiment 31 is Use of the spray formulation of any one of embodiments 1 to 22 for treating pruritus.

[0146] Embodiment 32 is a base formulation comprising hydrocortisone, a soothing agent, and a cooling agent, wherein the base formulation is suitable for application to the skin of a patient as a spray upon addition of a propellant.

[0147] Embodiment 33 is the base formulation of embodiment 32, wherein the cooling agent is a sensate molecule.

[0148] Embodiment 34 is the base formulation of embodiment 33, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof.

[0149] Embodiment 35 is the base formulation of embodiment 34, wherein the formulation comprises from about 0.1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of menthyl lactate.

[0150] Embodiment 36 is the base formulation of any one of embodiments 32 to 35, wherein the formulation further comprises an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, citric acid, and / or a humectant.

[0151] Embodiment 37 is the base formulation of any one of embodiments 32 to 36, wherein the formulation further comprises avenanthramides.

[0152] Embodiment 38 is the base formulation of embodiment 37, wherein the formulation comprises an oat extract containing avenanthramides.

[0153] Embodiment 39 is the base formulation of embodiment 38, wherein the formulation comprises from about 0.5 to about 2 wt. % of oat extract.

[0154] Embodiment 40 is the base formulation of any one of embodiments 32 to 39, wherein the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0155] Embodiment 41 is the base formulation of embodiment 40, wherein the soothing agent is Aloe vera.

[0156] Embodiment 42 is the base formulation of any one of embodiments 32 to 41, wherein the formulation comprises: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxydiglycol; ethyl alcohol; methyl gluceth-20; hydroxypropyl cellulose and optionally citric acid.

[0157] Embodiment 43 is the base formulation of embodiment 42, wherein the formulation comprises: from about 0.1 to about 5 wt. % of hydrocortisone; from about 0.05 to about 0.35 wt. % of Aloe vera; from about 0.5 to about 2 wt. % of menthyl lactate; from about 0.5 to about 2 wt. % of oat extract: from about 0.5 to about 2 wt. % of PEG-8; glycerin; from about 0.5 to about 2 wt. % of ethoxy diglycol; from about 75 to about 95 wt. % of ethyl alcohol; from about 0.5 to about 2 wt. % of methyl gluceth-20; and from about 0.5 to about 2 wt. % of hydroxypropyl cellulose.

[0158] Embodiment 44 is the base formulation of any one of embodiments 32 to 43, wherein the base formulation lacks a propellant.

[0159] Embodiment 45 is the base formulation of embodiment 44, wherein the propellant is isobutane or dimethyl ether.

[0160] Embodiment 46 is a container comprising the base formulation of any one of embodiments 32 to 45.

[0161] Embodiment 47 is a method of generating a spray formulation comprising mixing a base formulation of any one of embodiments 32 to 46 with a propellant to thereby generate the spray formulation.

[0162] Embodiment 48 is the method of embodiment 47, wherein the propellant is isobutane or dimethyl ether.

[0163] Embodiment 49 is the method of embodiments 47 or 48. further comprising packaging the spray formulation in a container.

[0164] Embodiment 50 is the method of embodiment 47, wherein the container is a bag- on-valve.

[0165] Embodiment 51 is a method of generating a spray formulation comprising: mixing hydrocortisone, a soothing agent, a cooling agent, avenanthramides. PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose to generate a base formulation; mixing the base formulation with a propellant to generate a spray formulation; and packaging the spray formulation in a container.

[0166] Embodiment 52 is the method of embodiment 51, wherein the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

[0167] Embodiment 53 is the method of embodiment 52, wherein the soothing agent is Aloe vera.

[0168] Embodiment 54 is the method of any one of embodiments 51 to 53, wherein the cooling agent is a sensate molecule.

[0169] Embodiment 55 is the method of any one of embodiments 51 or 54, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl but l ether, and combinations thereof.

[0170] Embodiment 56 is the method of embodiment 55 wherein the sensate molecule is menthyl lactate.

[0171] Embodiment 57 is the method of any one of embodiment 51 to 56, wherein the avenanthramides are provided as an oat extract containing avenanthramides.

[0172] Embodiment 58 is the method of any one of embodiments 51 to 57, wherein the container is a plastic container, a metal container, or a bag-on-valve.

[0173] Embodiment 59 is the method of any one of embodiments 51 to 58, wherein the propellant is isobutane or dimethyl ether.

[0174] Embodiment 60 is the method of any one of embodiments 51 to 59, wherein the method comprises mixing hydrocortisone, Aloe vera, a cooling agent, oat extract. PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and citric acid to generate a base formulation.

[0175] The invention further provides the following non-limiting alternate embodiments.

[0176] Alternate embodiment 1 is a spray formulation comprising hydrocortisone, Aloe vera, a cooling agent, and a propellant.

[0177] Alternate embodiment 2 is the spray formulation of alternate embodiment 1, wherein the spray formulation comprises from about 0.1 to about 5.0 wt. % of hydrocortisone.

[0178] Alternate embodiment 3 is the spray formulation of alternate embodiments 1 or 2, wherein the formulation comprises from about 0.05 to about 0.25 wt. % of Aloe vera.

[0179] Alternate embodiment 4 is the spray formulation of any one of alternate embodiments 1 to 3, wherein the formulation comprises from about 0.3 to about 1.5 wt. % of the cooling agent.

[0180] Alternate embodiment 5 is the spray formulation of any one of alternate embodiments 1 to 4, wherein the cooling agent is a sensate molecule.

[0181] Alternate embodiment 6 is the spray formulation of alternate embodiment 5, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vinyl butyl ether, and combinations thereof.

[0182] Alternate embodiment 7 is the spray formulation of alternate embodiment 5, wherein the sensate molecule is menthyl lactate.

[0183] Alternate embodiment 8 is the spray formulation of any one of alternate embodiments 1 to 7, wherein the propellant is selected from the group consisting of compressed air, compressed nitrogen, propane, n-butane, isobutane, dimethyl ether, carbon dioxide, nitrous oxide, hydrofluoroalkanes and combinations thereof.

[0184] Alternate embodiment 9 is the spray formulation of any one of alternate embodiments 1 to 8, wherein the propellant is isobutane.

[0185] Alternate embodiment 10 is the spray formulation of any one of alternate embodiments 1 to 8, wherein the propellant is dimethyl ether.

[0186] Alternate embodiment 11 is the spray formulation of any one of alternate embodiments 1 to 10, wherein the formulation comprises from about 25 to about 55 wt. % of the propellant.

[0187] Alternate embodiment 12 is the spray formulation of any one of alternate embodiments 1 to 11, wherein the formulation further comprises an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant.

[0188] Alternate embodiment 13 is the spray formulation of any one of alternate embodiments 1 to 12, wherein the formulation further comprises oat extract.

[0189] Alternate embodiment 14 is the spray formulation of alternate embodiment 13, wherein the formulation comprises from about 0.1 to about 3 wt. % of oat extract.

[0190] Alternate embodiment 15 is the spray formulation of any one of alternate embodiments 1 to 14, wherein the formulation further comprises ethyl alcohol, PEG-8, glycerin, methyl gluceth-20, ethoxydiglycol, and / or hydroxypropyl cellulose.

[0191] Alternate embodiment 16 is the spray formulation of any one of alternate embodiments 1-7 comprising: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG- 8; glycerin; ethoxydiglycol; ethyl alcohol; methyl gluceth-20; and hydroxypropyl cellulose.

[0192] Alternate embodiment 17 is the spray formulation of alternate embodiment 16 comprising: from 0.1 to about 5.0 wt. % of hydrocortisone; from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about 1.5 wt. % of menthyl lactate; from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1.5 wt. % of PEG-8; glycerin; from about 0.3 to about 1.5 wt. % of ethoxydiglycol; from about 40 to about 75 wt. % of ethyl alcohol; from about 0.3 to about 1.5 wt. % of methyl gluceth-20; and from about 0.3 to about 0.9 wt. % of hydroxy propyl cellulose.

[0193] Alternate embodiment 18 is the spray formulation of alternate embodiments 16 or 17 further comprising propellants isobutane or dimethyl ether.

[0194] Alternate embodiment 19 is the spray formulation of alternate embodiment 18 comprising from about 25 to about 55 wt. % of the propellant.

[0195] Alternate embodiment 20 is a container comprising the spray formulation of any one of alternate embodiments 1 to 19.

[0196] Alternate embodiment 21 is a kit comprising the spray formulation of any one of alternate embodiments 1 to 19 and instructions for use.

[0197] Alternate embodiment 22 is a method of treating skin of a patient in need thereof comprising applying the spray formulation of any one of alternate embodiments 1 to 19 to the skin of the patient.

[0198] Alternate embodiment 23 is the method of alternate embodiment 22, wherein the treating comprises cooling the skin and relieving an itch.

[0199] Alternate embodiment 24 is a localized method of cooling and relieving skin itch comprising topically applying the spray formulation of any one of alternate embodiments 1 to 19 to an area of itchy skin.

[0200] Alternate embodiment 25 is the method of alternate embodiment 24, wherein the skin itch is associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

[0201] Alternate embodiment 26 is use of the spray formulation of any one of alternate embodiments 1 to 19 in the manufacture of a medicament for treating pruritus.

[0202] Alternate embodiment 27 is use of the spray formulation of any one of alternate embodiments 1 to 19 for treating pruritus.

[0203] Alternate embodiment 28 is a base formulation comprising hydrocortisone, Aloe vera, and a cooling agent, wherein the base formulation is suitable for application to the skin of a patient as a spray upon addition of a propellant.

[0204] Alternate embodiment 29 is the base formulation of alternate embodiment 28. wherein the cooling agent is a sensate molecule.

[0205] Alternate embodiment 30 is the base formulation of alternate embodiment 30, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vinyl butyl ether, and combinations thereof.

[0206] Alternate embodiment 31 is the base formulation of alternate embodiment 28, wherein the formulation comprises from about 0.1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of menthyl lactate.

[0207] Alternate embodiment 32 is the base formulation of any one of alternate embodiments 28 to 31, further comprising an anti -infl ammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant.

[0208] Alternate embodiment 33 is the base formulation of any one of alternate embodiments 28 to 31. wherein the formulation comprises: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxydiglycol; ethyl alcohol; methyl gluceth- 20; and hydroxypropyl cellulose.

[0209] Alternate embodiment 34 is the base formulation of alternate embodiment 33, wherein the formulation comprises: from about 0.1 to about 5 wt. % of hydrocortisone; from about 0.05 to about 0.35 wt. % of Aloe vera; from about 0.5 to about 2 wt. % ofmenthyl lactate; from about 0.5 to about 2 wt. % of oat extract; from about 0.5 to about 2 wt. % of PEG-8; glycerin; from about 0.5 to about 2 wt. % of ethoxy diglycol; from about 75 to about 95 wt. % of ethyl alcohol; from about 0.5 to about 2 wt. % of methyl gluceth-20; and from about 0.5 to about 2 wt. % of hydroxypropyl cellulose.

[0210] Alternate embodiment 35 is the base formulation of any one of alternate embodiments 28 to 34, wherein the base formulation lacks a propellant.

[0211] Alternate embodiment 36 is the base formulation of alternate embodiment 35. wherein the propellant is isobutane or dimethyl ether.

[0212] Alternate embodiment 37 is a container comprising the base formulation of any one of alternate embodiment 28 to 35.

[0213] Alternate embodiment 38 is a method of generating a spray formulation comprising mixing a base formulation of any one of alternate embodiments 28 to 35 with a propellant to thereby generate the spray formulation.

[0214] Alternate embodiment 39 is the method of alternate embodiment 38, wherein the propellant is isobutane or dimethyl ether.

[0215] Alternate embodiment 40 is the method of alternate embodiments 38 or 39, further comprising packaging the spray formulation in a container.

[0216] Alternate embodiment 41 is a method of generating a spray formulation comprising: mixing hydrocortisone, Aloe vera, a cooling agent . oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose to generate a base formulation; mixing the base formulation with a propellant to generate a spray formulation; and packaging the spray formulation in a container.

[0217] Alternate embodiment 42 is the method of alternate embodiment 41, wherein the cooling agent is a sensate molecule.

[0218] Alternate embodiment 43 is the method of alternate embodiments 41 or 42, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vinyl buty l ether, and combinations thereof.

[0219] Alternate embodiment 44 is the method of alternate embodiment 43, wherein the sensate molecule is menthyl lactate.

[0220] Alternate embodiment 45 is the method of any one of alternate embodiments 41 to44, wherein the container is a plastic container or a metal container.

[0221] Alternate embodiment 46 is the method of any one of alternate embodiments 41 to45, wherein the propellant is isobutane or dimethyl ether.

[0222] While the invention has been described and illustrated herein by references to various specific materials, procedures, and examples, it is understood that the invention is not restricted to the particular combinations of material and procedures selected for that purpose. Numerous variations of such details can be implied as will be appreciated by those skilled in the art. It is intended that the specification and examples be considered as exemplary, only, with the true scope and spirit of the invention being indicated by the following claims. All references, patents, and patent applications referred to in this application are herein incorporated by reference in their entirety.

Claims

CLAIMSWhat is claimed is:

1. A spray formulation comprising hydrocortisone, a soothing agent, a cooling agent, and a propellant.

2. The spray formulation of claim 1, wherein the spray formulation comprises from about 0.1 to about 5.0 wt. % of hydrocortisone.

3. The spray formulation of claims 1 or 2, wherein the formulation comprises from about 0.05 to about 0.25 wt. % of the soothing agent.

4. The spray formulation of any one of claims 1 to 3, wherein the formulation comprises from about 0.3 to about 1.5 wt. % of the cooling agent.

5. The spray formulation of any one of claims 1 to 4, wherein the cooling agent is a sensate molecule.

6. The spray formulation of claim 5, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl but l ether, and combinations thereof.

7. The spray formulation of claim 5, wherein the sensate molecule is menthyl lactate.

8. The spray formulation of any one of claims 1 to 7, wherein the propellant is selected from the group consisting of compressed air, compressed nitrogen, propane, n-butane, isobutane, dimethyl ether, carbon dioxide, nitrous oxide, hydrofluoroalkanes and combinations thereof.

9. The spray formulation of any one of claims 1 to 8, wherein the propellant is isobutane.

10. The spray formulation of any one of claims 1 to 8, wherein the propellant is dimethyl ether.

11. The spray7formulation of any7one of claims 1 to 10, wherein the formulation comprises from about 25 to about 55 wt. % of the propellant.

12. The spray formulation of any one of claims 1 to 11, wherein the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil. shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

13. The spray formulation of claim 12. wherein the soothing agent is Aloe vera.

14. The spray formulation of any one of claims 1 to 13, wherein the formulation further comprises an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, and / or a humectant.

15. The spray formulation of any one of claims 1 to 14, wherein the formulation further comprises avenanthramides.

16. The spray formulation of claim 15, wherein the formulation comprises an oat extract containing avenanthramides.

17. The spray formulation of claim 16, wherein the formulation comprises from about 0. 1 to about 3 wt. % of the oat extract.

18. The spray formulation of any one of claims 1 to 17, wherein the formulation further comprises ethyl alcohol, PEG-8, glycerin, methyl gluceth-20, ethoxy diglycol, hydroxypropyl cellulose and / or citric acid.

19. The spray formulation of any one of claims 1 to 18 comprising: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxydiglycol; ethyl alcohol; methyl gluceth-20; and hydroxypropyl cellulose.

20. The spray formulation of claim 19 comprising: from 0. 1 to about 5.0 wt % of hydrocortisone: from about 0.05 to about 0.25 wt. % of Aloe vera; from about 0.3 to about 1.5 wt. % of menthyl lactate; from about 0.3 to about 1.5 wt. % of oat extract; from about 0.3 to about 1 .5 wt. % of PEG-8; glycerin; from about 0.3 to about 1 .5 wt. % of ethoxy di glycol; from about 40 to about 75 wt. % of ethyl alcohol; from about 0.3 to about 1.5 wt. % of methyl gluceth-20; and from about 0.3 to about 0.9 wt. % of hydroxy propyl cellulose.

21. The spray formulation of claims 19 or 20 further comprising propellants isobutane or dimethyl ether.

22. The spray formulation of claim 21 comprising from about 25 to about 55 wt. % of the propellant.

23. A container comprising the spray formulation of any one of claims 1 to 22.

24. A kit comprising the spray formulation of any one of claims 1 to 22 and instructions for use.

325. A bag-on valve filled with the spray formulation of any one of claims 1 to 22.

26. A method of treating skin of a patient in need thereof comprising applying the spray formulation of any one of claims 1 to 22 to the skin of the patient.

27. The method of claim 26, wherein the treating comprises cooling the skin and relieving an itch.

28. A localized method of cooling and relieving skin itch comprising topically applying the spray formulation of any one of claims 1 to 22 to an area of itchy skin.

29. The method of claim 28, wherein the skin itch is associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, poison ivy. oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis.

30. Use of the spray formulation of any one of claims 1 to 22 in the manufacture of a medicament for treating pruritus.

31. Use of the spray formulation of any one of claims 1 to 22 for treating pruritus.

32. A base formulation comprising hydrocortisone, a soothing agent, and a cooling agent, wherein the base formulation is suitable for application to the skin of a patient as a spray upon addition of a propellant.

33. The base formulation of claim 32, wherein the cooling agent is a sensate molecule.

34. The base formulation of claim 33, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof.

35. The base formulation of claim 34, wherein the formulation comprises from about 0.1 to about 5 wt. % of hydrocortisone, from about 0.05 to about 0.35 wt. % of Aloe vera, and from about 0.5 to about 2 wt. % of menthyl lactate.

36. The base formulation of any one of claims 32 to 35, wherein the formulation further comprises an anti-inflammatory agent, an antioxidant agent, a moisturizing agent, citric acid, and / or a humectant.

37. The base formulation of any one of claims 32 to 36, wherein the formulation further comprises avenanthramides.

38. The base formulation of claim 37, wherein the formulation comprises an oat extract containing avenanthramides.

39. The base formulation of claim 38, wherein the formulation comprises from about 0.5 to about 2 wt. % of oat extract.

40. The base formulation of any one of claims 32 to 39, wherein the soothing agent is selected from the group consisting of Aloe vera. hyaluronic acid, coconut oil. shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

41. The base formulation of claim 40, wherein the soothing agent is Aloe vera.

42. The base formulation of any one of claims 32 to 41, wherein the formulation comprises: hydrocortisone; Aloe vera; menthyl lactate; oat extract; PEG-8; glycerin; ethoxydiglycol: ethyl alcohol; methyl gluceth-20; hydroxypropyl cellulose and optionally citric acid.

43. The base formulation of claim 42, wherein the formulation comprises: from about 0.1 to about 5 wt. % of hydrocortisone; from about 0.05 to about 0.35 wt. % of Aloe vera; from about 0.5 to about 2 wt. % of menthyl lactate; from about 0.5 to about 2 wt. % of oat extract; from about 0.5 to about 2 wt. % of PEG-8; glycerin; from about 0.5 to about 2 wt.% of ethoxy diglycol; from about 75 to about 95 wt. % of ethyl alcohol; from about 0.5 to about 2 wt. % of methyl gluceth-20; and from about 0.5 to about 2 wt. % of hydroxypropyl cellulose.

44. The base formulation of any one of claims 32 to 43, wherein the base formulation lacks a propellant.

45. The base formulation of claim 44, wherein the propellant is isobutane or dimethyl ether.

46. A container comprising the base formulation of any one of claims 32 to 45.

47. A method of generating a spray formulation comprising mixing a base formulation of any one of claims 32 to 46 with a propellant to thereby generate the spray formulation.

48. The method of claim 47, wherein the propellant is isobutane or dimethyl ether.

49. The method of claims 47 or 48, further comprising packaging the spray formulation in a container.

50. The method of claim 47, wherein the container is a bag-on-valve.

51. A method of generating a spray formulation comprising: mixing hydrocortisone, a soothing agent, a cooling agent, avenanthramides. PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, and hydroxypropyl cellulose to generate a base formulation; mixing the base formulation with a propellant to generate a spray formulation; and packaging the spray formulation in a container.

52. The method of claim 51, wherein the soothing agent is selected from the group consisting of Aloe vera, hyaluronic acid, coconut oil, shea butter, ceramides, calendula, chamomile oil, blue tansy oil, evening primrose oil, bisabolol, and combinations thereof.

53. The method of claim 52, wherein the soothing agent is Aloe vera.

54. The method of any one of claims 51 to 53, wherein the cooling agent is a sensate molecule.

55. The method of any one of claims 51 or 54, wherein the sensate molecule is selected from the group consisting of menthol, menthyl lactate, menthyl ethylamido oxalate, menthyl ethylamido oxalate, vanillyl butyl ether, and combinations thereof.

56. The method of claim 55 wherein the sensate molecule is menthyl lactate.

57. The method of any one of claim 51 to 56, wherein the avenanthramides are provided as an oat extract containing avenanthramides.

58. The method of any one of claims 51 to 57, wherein the container is a plastic container, a metal container, or a bag-on-valve.

59. The method of any one of claims 51 to 58, wherein the propellant is isobutane or dimethyl ether.

60. The method of any one of claims 51 to 59, wherein the method comprises mixing hydrocortisone, Aloe vera, a cooling agent, oat extract, PEG-8, glycerin, ethoxy diglycol, ethyl alcohol, methyl gluceth-20, hydroxypropyl cellulose, and citric acid to generate a base formulation.

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