ANESTHETIC HEALING SPRAY THAT CAN BE SPRAYED OVER THE HEAD

Abstract

A sprayable composition containing up to 10% benzocaine, a skin protectant selected from the group consisting of petrolatum, mineral oil, glycerin, and a propellant. The benzocaine provides a cooling and / or numbing sensation to the treated area, while the skin protectant promotes skin healing. The composition can be sprayed onto the perineum, which can become sore, bruised, or even torn during childbirth. The composition can also be sprayed from the container when it is held upside down.

Description

Area

[0001] Aspects of the present disclosure relate generally to an anesthetic healing spray, and more specifically to an anesthetic healing spray that can be sprayed upside down from a container. background

[0002] Postpartum perineal pain is a common and often challenging problem that many women face after childbirth, especially after vaginal delivery. The perineum, the area between the vaginal opening and the anus, can be subjected to significant stress during the birthing process, leading to varying degrees of pain and discomfort.

[0003] During childbirth, particularly vaginal delivery, the perineum is subjected to intense pressure and stretching as the baby passes through the birth canal. This pressure can cause the perineum to become sore, bruised, or even tear. These tears can vary in severity, from minor superficial tears affecting only the skin to more severe lacerations extending into the deeper muscle layers of the perineum. In some cases, these natural tears may require stitches to heal properly, contributing to general discomfort.

[0004] An episiotomy, a surgical incision made by a healthcare provider to widen the vaginal opening during childbirth, can also contribute to postpartum perineal pain. Although episiotomies are less common today due to increased awareness of their potential complications, they may still be performed in certain situations to facilitate delivery. The incision itself, along with the healing process, can cause significant discomfort in the postpartum period.

[0005] In addition to tears and episiotomies, the physical strain and pressure exerted during childbirth can lead to swelling and bruising in the perineal area. This swelling is often a natural reaction to the trauma experienced during delivery, but it can cause persistent discomfort and make it difficult for new mothers to sit, walk, or even perform basic self-care tasks.

[0006] Another common problem that can worsen perineal pain after childbirth is the development of hemorrhoids. Hemorrhoids are swollen veins in the rectal area, often caused by the increased pressure and pushing during labor. These can be particularly painful and contribute to general discomfort in the perineal area.

[0007] The intensity of postpartum perineal pain can vary greatly from woman to woman, depending on several factors such as the extent of any tears, whether an episiotomy was performed, the presence of swelling or bruising, and the development of hemorrhoids. For some, the pain may be mild and manageable with over-the-counter pain relievers and home care, while others may experience more severe pain that requires medical intervention. Summary

[0008] Several aspects of this disclosure relate to sprayable compositions for pain relief and skin protection to promote healing in general. After childbirth, the perineal area may be sore, bruised, or torn, and the sprayable composition provides a non-contact, hygienic application method. For optimal comfort, these sprays should be designed to function upside down to ensure continuous delivery of the formulation. By using these ingredients and application methods, postpartum perineal pain can be effectively treated, promoting faster healing and providing much-needed pain relief.

[0009] Nozzle and spray failures are very common with aerosols. Formulation instability can cause an aerosol nozzle to fail or sputter due to several interrelated mechanisms. Formulation instability can lead to precipitation, thickening, or thinning within the nozzle or fluid pathways. This restricts or temporarily blocks fluid flow, causing sputtering or inconsistencies in the spray pattern. Instability that increases viscosity or creates solids can cause insufficient fluid pressure or flow through the nozzle. Insufficient fluid pressure or flow causes a propellant to mix unevenly with the liquid within the nozzle, resulting in sputtering or spurting that disrupts a consistent spray pattern. Components in an unstable formulation can settle or dry on the nozzle tip, altering the surface and impairing proper atomization.This causes an irregular spray flow and splashing. Changes in fluid properties, such as surface tension and viscosity, caused by instability, affect the atomization mechanism, leading to fluctuating droplet formation and thus splashing.

[0010] Surface tension and viscosity affect nozzle performance and can cause misfiring or spitting by interrupting the atomization process. If the surface tension is too high, the liquid resists breaking up into fine droplets, resulting in larger droplets or an irregular spray pattern, which leads to spitting or spraying from the nozzle. Conversely, too low a surface tension can cause an unstable spray pattern. In aerosols, a balanced surface tension can ensure uniform spray breakup and consistent droplet formation.

[0011] Increased viscosity makes it harder for the formulation to flow easily through narrow nozzle orifices, reducing the flow rate and increasing the pressure required to expel the liquid. High viscosity also delays the breakup of the liquid stream into fine droplets, resulting in longer liquid films or strands and larger droplets. This can cause spitting or inconsistent spray patterns, as the nozzle struggles to atomize the viscous liquid properly. Highly viscous liquids also tend to clog the nozzle or cause flow irregularities. If the formulation is too thin, the propellant will overwhelm the product, producing an inconsistent spray pattern. Spitting is typically a symptom of phase separation, precipitation, viscosity drift, or propellant / product incompatibility.

[0012] Additionally, sprayable formulations intended for postpartum recovery should be able to spread across the skin to provide adequate coverage of the perineal area. However, this can be challenging due to the variability of skin surface properties. If the surface tension of the sprayable formulation is too high, it may bead up on the skin and fail to spread properly, thus impairing its ability to deliver its intended benefits.

[0013] Surprisingly, it was found that adding certain surface tension modifiers to the sprayable composition can improve skin coverage without reducing viscosity or compromising stability, thus ensuring a consistent fine spray pattern. Specifically, a sprayable composition containing benzocaine, a skin protectant, a polyol, and a surface tension modifier, as well as mixtures thereof, was found to produce a fine mist with excellent coverage while maintaining viscosity, surface tension, and long-term stability.

[0014] One advantage of incorporating such a surface tension-modifying agent into the sprayable formulation is that it can lower the surface tension while maintaining the product's viscosity and stability. Another benefit is that it provides skin-conditioning advantages, along with increased skin absorption of active ingredients such as benzocaine.

[0015] Without being bound to any specific theory, it is assumed that in the sprayable composition described here, materials such as surfactants may lower the surface tension but could impair drug solubility and stability, potentially causing benzocaine crystallization. This could reduce the degree of usability and cause spraying problems such as sputtering, uneven spraying, weak spraying, or complete blockage. Solids may clog the dip tube or valve, resulting in sputtering, weak spraying, or complete blockage.

[0016] In one aspect of the present disclosure, the composition comprises 1 to 10% benzocaine, 1 to 25% of a skin protectant selected from the group consisting of petrolatum, mineral oil, glycerin, or a combination thereof, at least 1% propellant, and an aerosol carrier comprising a polyol. Benzocaine is a lipophilic ester and has a faster onset of action of approximately 30–60 seconds compared to other analgesics. However, the benzocaine is provided at a relatively high concentration (compared to other local anesthetics) to produce the desired pain-relieving effect. Given the chemical properties of benzocaine, the required higher concentration, and the inclusion of a sufficient amount of a skin protectant, carrier, and propellant, such a composition may not be generally suitable for delivery in a sprayable format.The present disclosure relates generally to such sprayable compositions that promote faster healing and provide much-needed pain relief.

[0017] The present disclosure also relates, in a broader sense, to spray arrangements for use in dispensing a sprayable composition from a container. The structure of the spray arrangement can be configured to be suitable for use with the specific sprayable compositions of the present disclosure. Several aspects of the present disclosure relate, in a broader sense, to compositions for an anesthetic spray that can be dispensed when the spray container is upside down, that is, when the dispensing end is below the bottom of the container. The spray formula comprises an analgesic and a skin protectant together with a propellant.The present disclosure addresses the problem of providing a desired quantity of both benzocaine and skin protectant while simultaneously providing a sprayable composition, including spraying when the container containing the spray formula is in an inverted position. Brief description of the drawings

[0018] In order to understand in detail the aforementioned features of the present revelation, a more precise description, briefly summarized above, can be given with reference to aspects, some of which are illustrated in the accompanying drawings. It should be noted, however, that the accompanying drawings illustrate only certain typical aspects of this revelation and are therefore not to be considered limiting to its scope, since the description may include other equally effective aspects. The same reference symbols in different drawings may identify the same or similar elements. Fig. Figure 1A presents a perspective view of a spray arrangement according to various aspects of the present disclosure. Fig. Figure 1B shows a perspective view of the spray arrangement of the Fig. 1A represents the spray composition being released or dispensed. Fig.2 represents a diagram with three images illustrating the operation of the spray arrangement of the Fig. 1A and Fig. Show 1B. Fig. Figure 3A presents a perspective view of a spray arrangement according to various aspects of the present disclosure. Fig. 3B shows a cross-sectional view of the spray arrangement of the Fig. 3A. Fig. 4A presents a perspective view of an application according to various aspects of the present disclosure. Fig. Figure 4B shows a cross-sectional view of the deployment of the Fig. 4A. Fig. Figure 5 shows a diagram of the viscosity of a spray composition measured in terms of the revolutions per minute of the rotational viscometer. Fig.Figure 6 presents a flowchart illustrating an example of a process 600 for providing pain relief and skin protection according to various aspects of the present disclosure. Detailed description

[0019] The detailed description presented below, in conjunction with the accompanying drawings, is intended to illustrate various configurations and is not meant to represent the only configurations in which the concepts described herein can be applied. The detailed description includes specific details to provide a comprehensive understanding of the various concepts. However, it will be evident to those skilled in the art that these concepts can also be applied without these specific details. In some cases, known structures and components are represented in block diagram form to avoid obscuring such concepts.

[0020] Based on the teachings, a person skilled in the art should recognize that the scope of the present disclosure is intended to cover every aspect of the present disclosure, whether implemented independently or combined with another aspect of the present disclosure. For example, a device may be implemented or a method practiced using any number of the aspects set forth herein. Furthermore, the scope of the present disclosure is intended to cover such a device or method practiced using a different structure, functionality, or a structure and functionality in addition to or different from the various aspects of the present disclosure set forth herein. It is understood that every aspect of the present disclosure may be embodied by one or more elements of a claim.

[0021] The word "exemplary" is used here to mean "serving as an example, instance, or illustration." Each aspect described here as "exemplary" is not necessarily to be interpreted as preferential or advantageous over other aspects.

[0022] Although certain aspects are described herein, many variations and permutations of these aspects fall within the scope of this disclosure. While some advantages and benefits of the preferred aspects are mentioned, the scope of this disclosure is not intended to be limited to any particular advantages, uses, or purposes. Rather, aspects of this disclosure are intended to be broadly applicable to various technologies, system configurations, networks, and protocols, some of which are illustrated by way of example in the figures and in the following description of the preferred aspects. The detailed description and drawings serve only to illustrate this disclosure and are not to be considered limiting, the scope of which is defined by the attached claims and their equivalents.

[0023] As used here, the terms “components”, “ingredients” and “materials” can be used interchangeably unless otherwise stated.

[0024] As used here, a “cosmetic product” means any substance and any component thereof intended to be rubbed, poured, injected, sprayed, inserted, or otherwise applied to a mammalian body or part thereof for cosmetic benefit. Cosmetic products may include substances recognized as generally safe (GRAS) by the U.S. Food and Drug Administration (FDA), food additives, and materials used in non-cosmetic consumer products, including over-the-counter drugs.A cosmetic product may include, but is not limited to, (i) chemicals, compounds, small or large molecules, extracts, formulations, or combinations thereof that are known to produce or cause at least one effect (positive or negative) on skin tissue; (ii) chemicals, compounds, small molecules, extracts, formulations, or combinations thereof that are not known to have an effect on skin tissue and that are discovered to produce or cause an effect on skin tissue using the methods and systems provided; and (iii) a compound or combination of compounds that, when applied to the skin, provide an acute and / or chronic benefit to the skin or a cell type commonly found therein. Cosmetic products may regulate and / or improve the skin or its associated cells (e.g.,Improvement of skin elasticity; improvement of skin hydration; improvement of skin condition; and improvement of cell metabolism).

[0025] As used here, “skincare” means the regulation and / or improvement of a skin condition. Some non-restrictive examples include improving the appearance and / or feel of the skin by making it smoother and more even; increasing the thickness of one or more layers of skin; improving the elasticity or firmness of the skin; improving the strength of the skin;and a reduction of the oily, shiny and / or dull appearance of the skin, an improvement in the hydration status or moisturization of the skin, an improvement in the appearance of fine lines and / or wrinkles, an improvement in skin exfoliation or flaking, a plumping of the skin, an improvement in skin barrier properties, an improvement in skin tone, a reduction in the appearance of redness or blemishes, a soothing of irritated skin and / or an improvement in the brightness, radiance or translucency of the skin; a prevention of skin damage through antioxidant approaches, including UV-A and UV-B induced damage, a prevention of comedone formation, a balancing of the skin microbiome or a prevention of acne.;

[0026] As used here, "skincare active ingredient" means a compound or combination of compounds that, when applied to skin, provide an acute and / or chronic benefit to the skin or a cell type commonly found therein. Skincare active ingredients can regulate and / or improve skin or its associated cells (e.g., improving skin elasticity, hydration, skin barrier function, and / or cell metabolism).

[0027] As used herein, the term “anesthetic topical application” means applying or spraying the compositions of the present disclosure onto the skin surface, in particular onto the perineal area.

[0028] The term “dermatologically acceptable carrier”, as used here, means that the carrier is suitable for topical application in body care to keratinous tissue without excessive toxicity, intolerance, instability, allergic reaction and the like, has good aesthetic properties and is compatible with all additional components of the skin care composition.

[0029] As used herein, the terms "plant extract," "natural extract," or "extract" in relation to a plant refer to any material extracted from natural resources, including plants. The whole plant or any part of the plant, including bark, berries, flowers, leaves, stems, stalks, peels, resins, rhizomes, roots, seeds, woods, and mixtures thereof, may be used for the extraction process. Extracts may be obtained using any suitable method known to a person skilled in the art, including: milling, crushing, maceration, infusion, percolation and decoction, Soxhlet extraction, microwave-assisted extraction, ultrasonically assisted extraction, sonication extraction, solvent extraction, accelerated solvent extraction, and supercritical fluid extraction. Suitable extraction solvents may include water, ketones, esters, C1 to C6 alcohols, hydrocarbons, and mixtures thereof.

[0030] As used here, the term "safe and effective amount" means an amount of a material, ingredient, compound, component or composition that is sufficient to induce a significant positive benefit, but is low enough to avoid serious adverse effects such as excessive toxicity or allergic reaction.

[0031] As used here, the term "skin" refers to the outermost protective layer of mammals, composed of cells such as keratinocytes, fibroblasts, and melanocytes. Skin comprises an outer epidermal layer and an underlying dermal layer. It may also include hair follicles, sebaceous glands, and nails, as well as other types of cells commonly associated with the skin, such as myocytes, Merkel cells, Langerhans cells, macrophages, stem cells, sebocytes, nerve cells, and adipocytes.

[0032] As used here, the terms "sensitive skin," "hypersensitive skin," and "stressed skin" can encompass irritable skin and intolerant skin. As used here, "irritable skin" refers to skin that reacts with pruritus—that is, itching or stinging—to various factors such as the environment, emotions, food, wind, rubbing, shaving, hard water with high calcium or other elemental concentrations, temperature fluctuations, humidity, or wool. As used here, "intolerant skin" refers to skin that reacts to various factors, such as the application of cosmetic or dermatological products or soaps, with sensations of overheating, tightness, tingling, and / or redness.

[0033] The terms "essentially free of" or "largely free of" may be used here. This means that the specified material is, at the very least, not intentionally added to the composition to form a part of it. The specified material, if present at all, may be present in an amount of less than approximately 0.5%, or less than approximately 0.01%, or less than approximately 0.0001%, or even 0%, based on the weight of the composition.

[0034] As used here, “ambient conditions” refers to a temperature of approximately 23 degrees Celsius (°C) and 50% relative humidity (RH).

[0035] As used here, “viscosity” means the viscosity at approximately 0.10 min⁻¹, determined by the Brookfield viscosity test method described below. In some examples, the viscosity may be greater than 0.10 min⁻¹.

[0036] A surface tension modifier refers to an agent that is effective in reducing the surface tension of a composition of the present disclosure. Typically, a suitable surface tension modifier is used in amounts effective in reducing the surface tension of the same composition without a surface tension modifier by at least about 10 mN / m, preferably by 15 mN / m, 20 mN / m or more.

[0037] As used here, the articles “a” and “an” are understood to mean one or more of the claimed or described materials, for example “a rheology modifier” or “an active ingredient”.

[0038] As used here, the terms “encompass”, “encompasses” and “comprehensive” are to be understood as non-restrictive.

[0039] Unless otherwise stated, all component or composition contents refer to the active fraction of that component or composition and exclude impurities, for example residual solvents or by-products, which may be present in commercially available sources of such components or compositions.

[0040] In this disclosure, all percentages are weight percentages of the total composition unless otherwise stated. All ratios are weight ratios unless otherwise stated.

[0041] It is understood that any maximum numerical limit specified in this description includes any lower numerical limit, as if such lower numerical limits were explicitly stated here. Any minimum numerical limit specified in this description includes any higher numerical limit, as if such higher numerical limits were explicitly stated here. Any numerical range specified in this description includes any narrower numerical range that falls within any such wider numerical range, as if such narrower numerical ranges were all explicitly stated here.

[0042] Active and other useful ingredients can be categorized or described here according to their cosmetic and / or therapeutic benefits or their postulated mode of action. However, it is understood that in some cases, the active and other useful ingredients may provide more than one cosmetic and / or therapeutic benefit or function through more than one mode of action. Therefore, the classifications made here are for the sake of simplicity and are not intended to restrict an ingredient to the specifically mentioned application or applications listed.

[0043] The compositions of the present invention may comprise, consist substantially of, or be composed of the essential components as well as the optional ingredients described herein. As used herein, "consisting substantially of" means that the composition or component may contain additional ingredients, but only if the additional ingredients do not substantially alter the fundamental and novel properties of the claimed compositions or processes.

[0044] As discussed, the intensity of perineal pain after childbirth can vary greatly from woman to woman, depending on several factors such as the extent of tearing, whether an episiotomy was performed, the presence of swelling or bruising, and the development of hemorrhoids. For some, the pain may be mild and manageable with over-the-counter pain relievers and home care, while others may experience more severe pain that requires medical intervention.

[0045] Topical analgesics are effective in treating perineal pain after childbirth because they provide localized relief with minimal systemic side effects. Local anesthetics such as benzocaine and lidocaine are particularly effective at numbing the perineal area, thus offering temporary relief from pain and discomfort. These anesthetics are available in various forms, including gels, sprays, and ointments.

[0046] The formula contains skin-protecting ingredients such as glycerin, petrolatum, and mineral oil, which provide additional skin-protecting benefits to support the healing process. Glycerin, also known as glycerol, is a versatile compound widely used in skincare for its moisturizing and healing properties. Glycerin promotes faster wound healing by creating an optimal environment for skin repair and maintaining moisture in the affected area. Glycerin is non-irritating and hypoallergenic, making it suitable for sensitive skin and allowing it to be applied to damaged or compromised skin without further irritation.

[0047] Petrolatum, commonly known as Vaseline, and mineral oil are also widely used in skincare for their protective and healing properties. Both are occlusive substances that form a protective barrier on the skin's surface to lock in moisture, prevent water loss, and keep the skin hydrated. Similar to glycerin, petrolatum and mineral oil can create an optimal environment for skin healing by maintaining moisture in the affected area, thereby accelerating perineal recovery. These ingredients are hypoallergenic and safe for use on sensitive skin, making them desirable for skin healing. All are included in the FDA's Skin Protectant Monograph (FDA Monograph M016).

[0048] Given that the perineal area can be sore, bruised, or torn after childbirth, a non-contact, hygienic application method, such as a spray, may be desirable. Postpartum sprays should be used after cleansing, ideally during a trip to the toilet. For optimal comfort, these sprays should be designed to function even when held upside down to ensure continuous delivery of the formula. Using these ingredients and application methods can effectively treat postpartum perineal pain, promoting faster healing and providing much-needed pain relief.

[0049] Some conventional postpartum pain sprays, such as Dermaplast Postpartum Spray and Lansinoh Pain Relief Spray, are designed to relieve perineal pain, itching, and discomfort. However, Dermaplast does not contain any skin-protecting or healing ingredients and contains acetylated lanolin alcohol, which can potentially cause skin irritation and sensitization. Similarly, although formulated for postpartum care, Lansinoh Pain Relief Spray lacks skin-protecting or healing ingredients and contains alcohol, lavender oil, and peppermint oil, all of which can cause skin irritation. Additionally, Lansinoh's pump spray system tends to clog and lose its functionality during use.

[0050] Conventional skin protectants or barrier sprays, such as "Dr. Butler's Pregnancy and Postpartum Spray," offer moisturizing, soothing, and protective benefits, but they do not spray reliably and lack pain-relieving properties. "Aquaphor Healing Ointment Body Spray," although a petrolatum-based cosmetic spray, is not designed for postpartum use and does not provide pain relief.

[0051] Conventional combination lotions, such as “Preparation H Rapid Relief Hemorrhoid Symptom Treatment Cream” with lidocaine and “Tucks 5% Lidocaine Cream”, combine an analgesic and a skin protectant in cream form that requires manual application.

[0052] Several aspects of this disclosure relate to a composition that offers both pain-relieving and skin-healing benefits in an upside-down spray format. Specifically, such aspects relate to an anesthetic spray that delivers a gentle mist containing benzocaine (an analgesic) and a skin protectant, in an aerosol can that can be sprayed upside down. The composition does not contain alcohols or other potential irritants that could impair the healing process. Potential skin irritants can include alcohols such as acetylated lanolin alcohol, lavender oil, peppermint oil, and other potentially irritating or drying ingredients. This spray is designed to be cooling and non-irritating, providing pain relief in the perineal and anal regions postpartum while simultaneously promoting skin healing by keeping the area moist.

[0053] The sprayable composition comprises an analgesic to provide a local cooling and anesthetic effect, a skin protectant, a carrier, a skin conditioner, and a propellant. The present disclosure can also be described as a formulation comprising an analgesic, a skin protectant, a skin conditioner, and a carrier, but lacking a propellant. The formulation can be prepared and then combined with the propellant when filling the container. The sprayable composition can also be referred to as a "spray" or a "pain and skin healing composition."

[0054] In some examples, the pain and skin healing composition includes up to 10% (20% in the propellant-free formulation) benzocaine, which is an effective local anesthetic. Other analgesics may also be used, such as lidocaine, capsaicin, salicylates, and menthol.

[0055] The pain and skin healing composition also contains up to 10% (20% in the propellant-free formulation) of petrolatum, mineral oil, glycerin, or a combination thereof, which act as skin protectants. In some such examples, the composition contains up to 25% of a skin protectant. Glycerin is preferred because of its non-greasy feel on the skin, although mixtures of petrolatum, mineral oil, and glycerin may also be used. Non-restrictive examples of skin protectants may include allantoin, colloidal oatmeal, and dimethicone. Examples of suitable petrolatum include: “Snow White Pet-C” from Calumet Specialty Products, Indianapolis, Ind. (melting range: 51-54°C), “Snow White V30” from Sonneborn, Parsippany, NJ (melting range: 55-64°C), Rajell WP1008AB5 Silkolene / Raj from Raj Petro Specialty P. Ltd., Mumbai, India (melting range: 65-68°C), Rajell WP 29 AJB from Raj Petro Specialty P. Ltd., (melting range: 63-69°C).), “Pet Blend 670 PG” from Calumet Specialty Products, (melting range: 64-72° C), Merkur 873 from Sasol Performance Chemicals, Hamburg, Germany (melting range: 55-64° C), equivalents thereof and mixtures thereof.

[0056] The composition uses up to 50% propellant, preferably dimethyl ether, a propellant known for its fast-drying and safer properties. The aerosol and aerosol weight percentage may be suitable for use with a specific insert and valve that reliably sprays upside down and ensures consistent application, as described in more detail below.

[0057] In some examples, the support for the composition can be a surfactant modifier. The support can comprise a polyol selected from the group consisting of polyhydric alcohols, polyethylene glycol, PPG-3-methyl ether-1,3-butylene glycol, propylene glycol, diglycerol, polyethylene glycol ethers of glycerol (e.g.,Glycereth 20), glycerol monopropoxylate, glycogen, hexylene glycol and extracts or derivatives thereof, hydrogenated starch hydrolysates, hydrolyzed mucopolysaccharides, inositol, glycosaminoglycans, methoxy-PEG-10, methylgluceth-10, methylgluceth-20, methyl glucose, 3-methyl-1,3-butanediol, polyethylene glycol and derivatives thereof (such as PEG-15-butanediol, PEG-4, PEG-5-pentaerythritol, PEG-6, PEG-8, PEG-9), pentaerythritol, 1,2-pentanediol, PPG-1-glyceryl ether, PPG-9,2-pyrrolidone-5-carboxylic acid and their salts such as glyceryl pea, saccharide isorate, sericin, silk amino acids, sodium acetylhyaluronate, sodium hyaluronate, sodium polyaspartate, sodium polyglutamate, sorbeth 20, sorbeth 6, sugars and sugar alcohols and derivatives thereof such as glucose, mannose and polyglycerol sorbitol, trehalose, triglycerol, trimethylolpropane, tris(hydroxymethyl)aminomethane salts and yeast extract, as well as mixtures thereof.Non-restrictive examples of polyhydric alcohols include glycerin, diglycerin, glycerol, erythritol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, maltitol, mannose, inositol, triethylene glycol, sodium pyrrolidone carboxylic acid (PCA), zinc PCA, and derivatives and mixtures thereof. In another respect, the spray composition may include one or more surfactant modifiers in addition to the one or more polyols.

[0058] The formulation may contain additional safe and effective amounts of skin conditioning agents. Non-restrictive examples of skin conditioning agents (also referred to as "skin soothing agents") suitable here include Aloe barbadensis (aloe) leaf juice, Hamamelis virginiana (witch hazel) extract, Avena sativa (oat) extract, green tea extract, chamomile extract and Centella asiatica, Zingibe officinale (ginger) root extract, panthenol, acid derivatives (including panthenol, dexpanthenol, ethyl panthenol), bisabolol, dipotassium glycyrrhizinate, pentylene glycol, 4-t-butylcyclohexanol, PEG-40 hydrogenated castor oil, hydroxypropylpropamidobenzoic acid, trideceth-9, propylene glycol, and mixtures thereof.Non-restrictive examples of suitable commercially available preservatives include SymSitive® (pentylene glycol, 4-t-butylcyclohexanol); SymCare® (pentylene glycol and 4-t-butylcyclohexanol and PEG-40 hydrogenated castor oil and trideceth-9 and hydroxypropylpropamidobenzoic acid and propylene glycol); and SymRelief® (bisabolol and Zingiber officinale (ginger) root extract), all available from Symrise, Holzminden, Germany. The skin conditioner can be provided in an amount of approximately 0.01 to 10%.

[0059] In conventional aerosol atomizers or spray cans, a liquid contained within is pressurized by a propellant in the container and expelled through a nozzle to form an atomized jet. The components of the spray can are the liquid and / or gaseous propellant, which generates the necessary pressure for spraying, and the actual product – the active ingredient or preparation to be sprayed. The product to be applied is gaseous or liquid and / or mixed with the propellant (propellant gas) within the can.

[0060] Due to the internal pressure in the aerosol can, its contents are precisely released as an aerosol when the spray nozzle is pressed. The success of this function lies in the mixture of the active ingredient and a liquid propellant inside the can. Part or all of the propellant is dissolved in the active ingredient, or part of it exists in gaseous form as a pressure cushion above the active ingredient / propellant mixture. When the valve in a spray device is activated, the gaseous propellant forces the contents out through the valve. At this moment, the propellant evaporates in fractions of a second, and the remaining active ingredient is dispersed finely and evenly.

[0061] Some formulations cannot be mixed directly with a propellant in the can. For example, the active ingredients / products / preparations to be released are often unstable in the presence of the propellant. Some formulations, such as emulsions, highly viscous gels, or oils, are difficult or impossible to spray.

[0062] In some examples, the propellant for the composition may be dimethyl ether, n-butane, isobutane, propane, or mixtures thereof. Dimethyl ether is preferred as a propellant due to its worldwide acceptance and fast-drying nature. In some examples, dimethyl ether is used in a 50 / 50 dilution with the formula to produce a drier spray. The sprayable composition may also contain a preservative such as pentylene glycol and / or -t-butylcyclohexanol. Other components may also be added to modify the solubility or dispersibility of the composition.

[0063] The nozzle, actuator, and valve configuration is designed to ensure that the composition is reliably sprayed with a uniform spray pattern and output. The spray formulation may be suitable for specific valves and / or nozzles.

[0064] Benzocaine, an ester and lipophilic, has a faster onset of action of 30-60 seconds compared to lidocaine, making it a preferred active ingredient. However, benzocaine is required at a higher concentration of 5-20% for pain relief, making it difficult to find a suitable carrier that can dissolve both the high amount of benzocaine and the skin protectant. Methods for the preparation of exemplary compositions

[0065] The compositions of the present invention can generally be prepared using conventional methods, such as those known in the technology for manufacturing sprayable, non-aqueous compositions. Such methods typically involve mixing the ingredients in one or more steps in a relatively homogeneous state, with or without heating, cooling, applying a vacuum, and the like. Systems with less than 5% water are typically considered non-aqueous and are single-phase. They can be prepared by first mixing the carriers, gently heating them, then adding active ingredients such as liquids or powders, finally cooling, and adding additional skin-conditioning ingredients. The compositions can preferably be prepared to optimize stability (e.g., physical stability, chemical stability) and / or the release of the active ingredients.

[0066] Table 1 below shows the composition for several example spray formulations. Table 1: composition function Example 1Wt %active Example 2Wt %active Example 3Wt %active Example 4Wt %active 1 Benzocaine, USP Painkillers 10 5 5 2.5 2 Glycerin 99.7% Skin protectant 10 12.5 12.5 22.5 3 Petrolatum Skin protectant 0 2.5 0 0.5 4 mineral oil Skin protectant 0 0 2.5 0 5 Polyethylene glycol carrier rest rest rest rest 7 PPG-3 methyl ether carrier 3.0 5 5 1.5 8 Hamamelis virginiana (witch hazel) extract skin-soothing 0.5 0 0 0 9 Aloe barbadensis leaf juice skin-soothing 0 0.5 0 0.1 10 Oat extract skin-soothing 0 0 0.05 0 11 Pentylene glycol preservatives 0.7 0 0 0.7 12 4-t-Butylcyclohexanol preservatives 0.3 0 0 0.3 13 Dimethyl ether propellant 50 50 50 50

[0067] The Fig. 1A and Fig.Figure 1B shows a spray arrangement 100 for use in dispensing a sprayable composition. The spray arrangement 100 can be specified for reliable and uniform performance. The spray arrangement 100 can be coupled to a container (not shown), for example, by pressing the edges of the spray arrangement against the edges of a cylindrical container. The spray arrangement 100 includes a valve 102, which is arranged in a valve holder 104. The valve 102 is also in contact with a housing 106, and a spring 108 presses the valve 102 against a seal 114 to close the spray arrangement 100 in the absence of an external force by a user to move the valve 102. The spray arrangement 100 also includes a dip tube 110, which extends downwards and into the container. The dip tube 110 can extend to the bottom of the container, so that substantially all of the liquid contents can be ejected from the container.When the spray arrangement 100 is positioned upright, as shown in the . Fig. 1A and Fig.As shown in Figure 1B, a ball 112 is in a lower position, blocking a second opening 113 in the dip tube 110. When the spray assembly 100 is rotated so that it is essentially upside down, the ball 112 moves out of the second opening 113, allowing the spray formulation to enter the dip tube 110 through the second opening 113 and subsequently flow into the housing 106. An actuator 116 is connected to the top of the valve 102, so that when the actuator 116 is pressed downwards, the valve 102 is displaced from its rest position, and the composition flows through a gap between the valve 102 and the housing 106 and into a fluid path 117 in the actuator 116. An insert 118 is arranged, coupled to the actuator 116, and the insert 118 includes an opening 120 through which the spray formulation passes and is emitted as a mist.

[0068] The valve 102 can have a height of at least 6 mm before crimping. In some configurations, the height of the valve 102 before crimping can be 6.10–6.96 mm. In some configurations, the height after crimping can be 6.93–7.95 mm. The seal 114 can be made of materials such as, but not limited to, BUNA, neoprene, butyl, or Viton, provides a seal to prevent leakage, and can have a height of at least 4 mm. In some configurations, the height of the seal 114 can be 4.95–5.21 mm. The valve holder 104 can be made of aluminum and have an outer diameter of at least 32 mm. It is designed to be pressed onto the container to ensure a secure fit and can have initial crimping dimensions of at least 27 mm for the valve holder on an aluminum container.In some configurations, the outer diameter of the valve holder 104 is 32.5 mm. Additionally, in some configurations, the initial crimp dimension can be 27.05 to 27.31 mm. In some configurations, the outer diameter can be 1.280–1.290 inches (32.51–32.77 mm). The spring 108 can be a stainless steel spring that provides the necessary force to return the valve 102 to its closed position after dispensing. A housing 106 can be made of nylon or other suitable materials. The ball 112 can be a stainless steel ball that helps control the product flow. The dip tube 110 can be made of polyethylene or other suitable materials, and the dip tube 100 extends into the spray formulation in the container, allowing the spray formulation to be drawn in and dispensed through the valve 102. The dip tube dimension can be specified as a minimum of 2 mm.

[0069] The actuator 116 can be made of a polymer, such as polypropylene (PP) or polyethylene terephthalate (PET), or of another material. The actuator 116 can also include a finger rest and side grips with a textured or custom-designed surface for improved handling. The insert 118 can be made of a material such as, but not limited to, polyoxymethylene (POM). A valve holder can be made of, for example, tinplate or aluminum and have an outer diameter of at least 32 mm. The combination of the valve 102, the insert 118, and the actuator 116 produces a fine mist spray with a uniform spray pattern and output.

[0070] Fig.Figure 2 illustrates how the spray composition moves through the spray assembly 100. In the left image, the spray assembly 100 is in a resting state. The liquid product has not yet entered the valve 102 and is not sprayed. The spring 108 and the actuator 116 are in their standard positions. In the middle image, the composition flows into the valve 102 and moves upwards. As the composition moves through the fluid path 117 of the actuator 116, the insert 118 helps to guide the composition and produce the desired spray characteristics. In the right image, the composition flows out of the opening 120 of the insert. The composition is ejected as a spray mist, and the propellant evaporates almost immediately.

[0071] The Fig. 3A and Fig.Figure 3B illustrates a spray arrangement 200 comprising an actuator 216 and an insert 218 having an opening 220 for dispensing a spray formulation as a mist. Fig. Figure 3B shows a cross-sectional view of the spray assembly 200. The actuator 216 includes a fluid path 217 that connects the interior of a container to the opening 220 when the actuator 216 is pressed. The spray assembly 200 can be operated both upside down and upright. The ability of a spray assembly to operate upside down is important for use in a postpartum pain spray to facilitate operation.

[0072] The Fig. 4A and Fig.Figure 4B illustrates insert 218, as described above. The opening 220 of insert 218 is dimensioned to provide the desired mist characteristics, such as a fine mist. The size of the opening can be selected according to the specific spray formulation. The opening size can have a diameter of approximately 0.005 to 0.05, including approximately 0.007 to approximately 0.025.

[0073] The dimensions and materials described for the spray arrangement are exemplary. Aspects of the present disclosure are not limited to these dimensions, as other dimensions are considered.

[0074] Since the spray formulation of the present disclosure may contain up to 10% analgesic and up to 10% skin protectant, the amount of propellant provided cannot constitute a high weight percentage of the spray formulation. Therefore, the present disclosure provides a spray composition that can be dispensed as a mist using various spray arrangements. Brookfield viscosity test method

[0075] The viscosity of samples can be measured using a standard viscometer, such as a Brookfield DV2T viscometer (manufactured by Brookfield Ametek, Middleboro, MA, USA), which is equipped with a helical disc or cylindrical spindle. The viscometer is leveled, set up, and calibrated according to the manufacturer's standards. The viscometer speed (rpm) is selected so that the measured viscosity falls within the manufacturer's recommended settings (e.g., 5 rpm).

[0076] Samples are stored in sealed glass containers with an opening and an inner diameter of at least 40 mm and carefully filled to a height of at least 50 mm to avoid trapped air bubbles. Centrifugation can be used to remove any trapped gas or air. The sample containers are equilibrated for at least 24 hours at 23°C ±2°C and approximately 50% ± 2% relative humidity before measurement.

[0077] Viscosity is measured at 23°C ±2°C and approximately 50% ±2% relative humidity by placing the uncovered sample vessel under the viscometer and lowering the viscometer until the top of the disk or cylinder touches the sample surface. The descending helix ("helipath") is activated and a timer is started as soon as the top of the disk or cylinder touches the sample surface. A reading is taken approximately every 10 seconds over a period of about 45 seconds to about 1 minute. The viscosity is calculated as the arithmetic mean of the recorded viscosities. Care is taken to ensure that the spindle does not touch the glass vessel.

[0078] Fig.Figure 5 presents a viscosity diagram showing the measured viscosity versus the revolutions per minute (rpm) of the viscometer. An example 1, as shown in Table 1, exhibits a higher viscosity at 0.1 rpm, and the viscosity measurements are lower with increasing rpm. In rheology, such fluid behavior is called "shear thinning," which is the non-Newtonian behavior of fluids whose viscosity decreases under shear deformation. Examples of fluids exhibiting shear thinning include ketchup, which flows when squeezed from a container but generally retains a shape once sprayed onto a surface. Such fluid behavior is due to the polymeric components and results in small droplets as the spray formulation leaves the spray arrangement.The high viscosity at low rpm indicates that the formulation will adhere to the target skin area to fulfill the desired cooling and skin protection functions.

[0079] This high viscosity measurement at 0.1 rpm indicates that the formulation will exhibit good static stability and resist separation. Furthermore, it shows Fig. 5. A flattening of the viscosity measurement with increasing rpm, which suggests that the formulation will result in small droplets with a narrow droplet size distribution and uniform coverage of the target spray area. Surface tension test method

[0080] In accordance with EU Regulation A.5 (EC) No 440 / 2008, Annex, Official Journal of the European Union L142 / 1, surface tension was measured using the plate method (OECD Guidelines for testing of chemicals, 115, 27 July 1995).

[0081] Prior to sample testing, the surface tension of Barnstead GenPure Pro water was tested for verification purposes. The surface tension of the water was measured at 72.58 mN / m at 22.4°C, which is within the acceptable tolerance of the literature value (72.37 mN / m at 22.5°C).

[0082] Surface tension was measured on a single sample using the Wilhelmy plate method on a Krüss K11 tensiometer in duplicate measurements (each measurement being an average of 10 sequential analyses). In these experiments, a platinum rod probe is suspended from a balance and brought into contact with the liquid surface. The forces experienced by the balance as the probe interacts with the liquid surface can be used to calculate the surface tension. The probe used is a platinum rod with a wetted length of 6.283 mm. The instrument resolution is 0.01 mN / m. No correction calculation is required for the plate method according to the instrument manual. The surface tension is calculated using the following equation: σ=F / L⋅cosθ where σ=surface tension; F=force acting on the scale; L=wetted length; θ=contact angle.

[0083] The sample proved to be insoluble in water; therefore, it was tested undiluted. The sample was analyzed at 20°C. The sample temperature was determined immediately prior to surface tension measurement using a NIST-traceable thermometer with an accuracy of ±0.2°C (serial number 230859189, retest date 12-19-2025). Each surface tension measurement consists of data collected over 10 seconds at 1-second intervals, with the average surface tension being reported.

[0084] The surface tension of the formulation can be lower than that of water (72 mN / m). In some formulations, the surface tension can be less than approximately 50 mN / m at around 20 to 25 °C. Lower surface tension reduces the cohesive forces at the liquid surface, allowing the liquid to break up more easily into smaller droplets when sprayed. This results in finer droplets, which provide better coverage and more efficient use of the sprayed composition. Lower surface tension can increase surface wetting and improve the adhesion and efficacy of the sprayed composition on the skin.

[0085] The described ingredients and composition are examples only. Aspects of this disclosure are not limited to specific compositions and / or ingredients, as other ingredients and compositions are under consideration. In some examples, the amount of propellant may be more than 50%. For example, the amount of propellant may be 65% (or more). In other examples, the amount of propellant may be less than 50%.

[0086] As discussed, various aspects of the present disclosure provide a dual-acting anesthetic healing spray, uniquely formulated and administered to relieve pain and promote healing in sensitive skin areas, particularly in the perineal region after childbirth. Various aspects combine a local anesthetic, such as benzocaine, in clinically effective concentrations with one or more skin protectants, including glycerin, petrolatum, and mineral oil, in a sprayable composition. The composition further includes a polyol-based carrier and a propellant, preferably dimethyl ether, which together ensure solubility, stability, and spray performance.The formulation is specifically designed to deliver a fine, uniform mist while functioning reliably even when the spray container is held upside down, enabling hygienic, touchless application by postpartum patients. The spray exhibits shear-thinning rheological properties that ensure static stability within the container while producing small, uniform droplets that adhere to the skin without excessive runoff. Further features include specialized spray arrangements incorporating a valve, actuator, and insert, designed to deliver the composition at consistent rates and droplet sizes, even when the container is inverted.Unlike conventional sprays, the present invention avoids the addition of alcohols, essential oils, and other potential irritants, providing a cooling, non-irritating, and fast-drying spray tailored for application to highly sensitive tissue. Together, these features offer a composition and delivery system that address the shortcomings of previous postpartum sprays, enabling reliable pain relief and improved healing in a safe, user-friendly format.

[0087] In some examples, the anesthetic component is not limited to benzocaine but may include other local analgesics such as lidocaine, pramoxine, dyclonine, capsaicin, menthol, or salicylates, either alone or in combination. In some examples, benzocaine may be combined with lidocaine to provide multimodal pain relief with varying onset and duration of action. In other examples, the composition may additionally include anti-inflammatory agents such as bisabolol, hydrocortisone acetate, or ginger root extract to reduce swelling, or antimicrobial agents such as benzalkonium chloride, chlorhexidine, or silver particles for infection prevention. In some embodiments, the delivery system may include solubilizers such as cyclodextrins, liposomes, or nanoemulsions to enhance the delivery of the anesthetic and protective agents.The propellant is not limited to dimethyl ether; other acceptable propellants may include isobutane, propane, hydrofluoroalkanes, or compressed air and nitrogen. In some examples, the spray arrangement may incorporate a bag-on-valve system or a barrier separator packaging to ensure propellant and formulation stability and to enable 360° spraying. The spray actuation device may also be configured to dispense metered doses or a continuous spray stream, and the insert orifice may be varied to produce droplet size distributions tailored to different applications.In some examples, the spray is used for skin conditions beyond perineal pain after childbirth, including hemorrhoids, anal fissures, insect bites, minor cuts, abrasions, burns, post-operative discomfort, or for general pain relief in sensitive areas.

[0088] In some examples, a process for manufacturing the anesthetic healing spray involves preparing a formulation by combining benzocaine with a skin protectant and a carrier to form a homogeneous solution or dispersion. The formulation is then filled into an aerosol can along with a propellant, such as dimethyl ether, in a predetermined ratio to ensure sprayability and stability. Once the can is filled, a spray assembly is attached to it by compression, creating a sealed container capable of dispensing the composition as a mist. The spray assembly may include a valve, actuator, seal, spring, insert, and dip tube, designed to function when the container is inverted. The result is a finished product that is shelf-stable, portable, and ready to use for postpartum pain relief and skin healing.

[0089] In some examples, a method for providing pain relief and skin protection involves providing a user with a container pre-filled with an anesthetic healing composition comprising benzocaine, a skin protectant, a carrier, and a propellant. The container contains a spray device designed to atomize and dispense the composition as a fine mist. When the spray is applied to the desired area of ​​skin, such as the perineum, the composition, due to the benzocaine, provides a localized cooling and numbing sensation while simultaneously depositing a skin protectant layer that promotes tissue healing and moisture retention. The spray device is specifically designed to function in an inverted position, enabling hygienic, touchless application to sensitive areas of the body.

[0090] Fig. Figure 6 presents a flowchart illustrating an example of Process 600 for providing pain relief and skin protection according to various aspects of the present disclosure. Process 600 can be used in conjunction with a sealed aerosol container containing a composition comprising benzocaine in an amount of about 1 to 10%, a skin protectant in an amount of about 1 to 25%, a carrier, and a propellant. The container may further include a spray arrangement configured to dispense the composition as a mist. Process 600 can be performed by a user, e.g., a human being. As in the example of Fig.As shown in Figure 6, process 600 begins in block 602, with the user positioning the container in an orientation suitable for the application. The spray arrangement is capable of spraying even when the container is held upside down. In block 604, the user actuates the spray arrangement by pressing an actuator to open a valve from its closed position, thereby releasing the composition into a fluid path within the actuator. In block 606, the container dispenses the composition as a fine mist through an opening in an insert. The propellant can evaporate rapidly to produce a cooling sensation. The mist dispensed from the container can be applied directly to the desired area of ​​skin, which in certain embodiments includes the perineal area, to provide localized analgesia and skin protection.In Block 608, the user allows the applied formulation to adhere to the skin's surface. The benzocaine provides temporary pain relief, while the skin protectant promotes healing and maintains hydration.

[0091] As used here, the term "determine" encompasses a wide variety of actions. For example, "determine" can include calculating, arithmetic, processing, deriving, investigating, looking up (e.g., looking up in a table, database, or other data structure), ascertaining, and the like. Additionally, "determine" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), and the like. Furthermore, "determine" can include resolving, selecting, choosing, setting, and the like.

[0092] As used here, a phrase referring to "at least one of" a list of elements refers to any combination of those elements, including individual members. For example, "at least one of: a, b, or c" is intended to cover: a, b, c, ab, ac, bc, and abc.

[0093] The methods disclosed herein comprise one or more steps or actions for achieving the described process. The process steps and / or actions can be interchanged without departing from the scope of protection of the claims. In other words, unless a specific sequence of steps or actions is specified, the sequence and / or use of specific steps and / or actions can be changed without departing from the scope of protection of the claims.

[0094] It is understood that the claims are not limited to the precise configuration and components described above. Various modifications, changes, and variations can be made to the arrangement, operation, and details of the methods and devices described above without departing from the scope of the claims. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited non-patent literature

[0000] In accordance with EU Regulation A.5 (EC) No 440 / 2008, Annex, Official Journal of the European Union L142 / 1, surface tension was determined using the plate method (OECD Guidelines for the Testing of Chemicals, 115, 27 July 1995

[0080]

Claims

[1] Composition which has: 1 to 10% benzocaine; 1 to 25% of a skin protectant selected from the group consisting of petrolatum, mineral oil, glycerin or a combination thereof; at least 1% propellant; and a carrier comprising a surface tension modifier. [2] Composition according to claim 1, wherein the benzocaine is present in an amount of 10 wt.% of the composition. [3] Composition according to claim 1 or 2, wherein the skin protectant is present in an amount of 10% by weight of the composition. [4] Composition according to claim 1 or 2, wherein the skin protectant is glycerin and the glycerin is present in an amount of about 1 to 10%. [5] Composition according to any one of claims 1 to 4, wherein the carrier is a polyol. [6] Composition according to any one of claims 1 to 5, further comprising one or more skin conditioning agents, wherein the one or more skin conditioning agents preferably comprise one or more of aloe vera, witch hazel or oat extract. [7] Composition according to any one of claims 1 to 6, wherein the blowing agent is dimethyl ether, wherein the blowing agent preferably comprises about 50 wt.% of the composition, and wherein the carrier more preferably comprises polyethylene glycol and PPG-3 methyl ether. [8] Composition according to any one of claims 1 to 7, wherein the composition does not contain alcohol, lavender oil and peppermint oil, and wherein the spray arrangement preferably functions when the spray arrangement is substantially upside down. [9] Composition according to any one of claims 1 to 8, wherein the composition is sprayed from a container with a spray arrangement (100; 200), the spray arrangement comprising: a valve (102) which is connected to the container via a valve attachment (104), a housing (106) connected to the valve, a seal (114) arranged between a part of the valve and a section of the housing, a spring (108) which is arranged to keep the valve in a closed state, an actuator (116) which is configured to be pressed in order to release the valve from the closed state and spray the composition, and an insert (118) connected to the actuator, the insert having an opening through which the composition passes, the spray arrangement preferably further comprising a dip tube (110) connected to the housing, the dip tube extending downwards from the housing and the dip tube having a first opening to draw the composition into the dip tube, the spray arrangement preferably further comprising a ball (112) configured to block a second opening when the container and the spray arrangement are positioned in a substantially upright position, and when the container and the spray arrangement are in a substantially upside-down position, the ball moves away from the second opening to allow the composition to enter the dip tube, the second opening being located near the valve attachment of the spray arrangement.and wherein the spray arrangement preferably further comprises, wherein the valve has a height of at least 6 mm before compression and the insert has an opening diameter of about 0.007 to 0.025 mm. [10] Method for producing the composition according to claim 1, wherein the method comprises: Formulating a formulation containing the benzocaine, the skin protectant, and the carrier; and Filling a can with the formulation and propellant, and Sealing the can by pressing a spray arrangement onto the can. [11] Method for providing pain relief and skin protection for a skin area, the method comprising: Providing a container with a composition comprising benzocaine, a skin protectant, a carrier and a propellant, wherein the benzocaine is present in an amount of about 1 to 10% and the skin protectant is present in an amount of about 1 to 25%, and the container comprising a spraying arrangement configured to spray the composition as a mist from the container, Apply the mist to the skin area to create a cooling sensation and promote healing. [12] Method according to claim 11, wherein the skin area comprises the perineum. [13] Method according to claim 11 or 12, wherein the spray arrangement comprises: a valve that is coupled to a container via a valve fitting, a housing that is coupled to the valve, a seal that is positioned between part of the valve and a section of the housing, a spring designed to keep the valve in a closed position, an actuator designed to be pressed in order to release the valve from the closed state and spray the composition, and an insert coupled to the actuator, wherein the insert includes an opening through which the composition passes.

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