Topical compositions for pain relief

Abstract

The present invention provides a topical composition for pain relief containing a topical analgesic and a volatile emollient and / or absorbent. The topical composition is substantially free of volatile alcohols. The topical composition can be used to relieve pain in a user having sensitive skin. In addition, the invention includes a method of relieving pain in a user having sensitive skin. The method comprises topically applying a composition comprising a topical analgesic and a volatile emollient and / or absorbent to an external skin portion of the body of the user in need of pain treatment.

Description

Technical Field

[0001] The present invention relates to topical compositions for pain relief; the topical compositions are particularly useful for pain relief in users with sensitive skin. More specifically, the present invention relates to a topical composition comprising a topical analgesic and a volatile emollient and / or an absorbent. The topical composition is substantially free of volatile alcohols. Furthermore, the present invention relates to methods of relieving pain, particularly in users with sensitive skin. In particular, such methods comprise topically applying a composition comprising a topical analgesic and a volatile emollient and / or an absorbent to an external skin portion of a user's body. Background Art

[0002] "Sensitive skin" is defined as skin on any part of the body that is subject to discomfort at any given time. Examples of conditions that cause sensitive skin may include, but are not limited to, acne, contact dermatitis, dry skin, itchy skin, and eczema. Sensitive skin may be described as skin that is "reactive" or presents special needs to external stimuli. Examples of external stimuli may include sunlight, wind, water, air temperature, air humidity, skin and body hydration, diet, and / or contact with chemical or physical materials.

[0003] Consumers with sensitive skin often find it difficult to find topical cosmetics or pharmaceuticals that do not irritate or further irritate their skin. This is particularly detrimental to sensitive skin consumers who have health or beauty concerns (i.e., concerns unrelated to their sensitive skin) that are typically addressed through topical skin treatments. One such example may be a sensitive skin consumer who also suffers from body pain (e.g., pain in the neck, forearm, elbow, upper arm, wrist, calf, thigh, knee, back, shoulder, hip, and / or ankle).

[0004] Pain is a common experience that can last for a short time (known as "acute pain") or for a longer period of time, such as six months or more (known as "chronic pain"). Pain can negatively impact a person's quality of life, and pain treatment can be expensive. Effective and inexpensive pain treatment options are desirable.

[0005] Topical pain creams are commonly used to treat body pain. Currently, there are various forms of topical pain creams on the consumer market. However, such creams often give users an irritating experience, causing dry skin, redness, irritation, overly strong cooling or warming sensations and / or strong odors. Such creams are not suitable for consumers with sensitive skin.

[0006] Therefore, there is a need for topical pain relief compositions that provide a gentler experience for users or consumers with sensitive skin. Such topical compositions can be used, for example, as daily care, leave-on products. Summary of the invention

[0007] According to one example, a topical composition for pain relief may include a topical analgesic and a volatile emollient; wherein the topical composition is substantially free of volatile alcohols. Such a topical composition may be suitable for users with sensitive skin.

[0008] According to one example, the amount of the topical analgesic may be 0.5 wt % to 8 wt %. According to one example, the topical analgesic may be one or more of lidocaine or benzocaine. According to another example, the topical analgesic may be lidocaine, for example, in an amount of about 4 wt %.

[0009] According to one example, the amount of the volatile emollient may be 1 wt % to 12 wt %. According to another example, the amount of the volatile emollient may be about 4 wt % to about 8 wt %. According to one example, the volatile emollient may provide a local cooling sensation. According to another example, the volatile emollient may be isododecane.

[0010] According to one example, the topical composition may further include an absorbent. According to one example, the amount of the absorbent may be 0.1 wt % to 5 wt %. According to another example, the absorbent may be a processed oat component. According to one example, the processed oat component may be colloidal oatmeal powder. According to one example, the amount of the colloidal oatmeal powder may be about 1 wt %.

[0011] According to one example, the topical composition can be substantially free of additional cooling agents, such as menthol and lactated menthol.

[0012] According to one example, a method of relieving pain in a user with sensitive skin may include the step of applying a topical composition to an external skin portion of a user's body in need of pain treatment. The topical composition may include a topical analgesic and a volatile emollient; and the topical composition may be substantially free of volatile alcohol.

[0013] According to another example, a method of relieving pain in a user with sensitive skin may include topically applying a composition comprising lidocaine and isododecane to an external skin portion of a user's body in need of pain treatment; wherein the composition is substantially free of volatile alcohols. According to one example, the amount of lidocaine may be 0.5 wt % to 8 wt %, and the amount of isododecane may be 1 wt % to 12 wt %. According to another example, the composition may also include a processed oat component. According to one example, the amount of the processed oat component may be 0.1 wt % to 5 wt %.

[0014] According to an alternative example, a topical composition may include a topical analgesic and an absorbent; wherein the topical composition is substantially free of volatile alcohol.

[0015] According to one example, the amount of the topical analgesic may be 0.5 wt % to 8 wt %. According to one example, the topical analgesic may be one or more of lidocaine or benzocaine. According to another example, the topical analgesic may be lidocaine. According to one example, the amount of lidocaine may be about 4 wt %.

[0016] According to one example, the amount of the absorbent may be 0.1 wt % to 5 wt %. According to one example, the absorbent may be a processed oat component. According to one example, the processed oat component may be colloidal oatmeal powder. According to one example, the amount of the colloidal oatmeal powder may be about 1 wt %.

[0017] According to one example, the topical composition can be substantially free of additional cooling agents, such as menthol and lactated menthol.

[0018] According to one example, a method of relieving pain in a user with sensitive skin includes the step of applying a topical composition to an external skin portion of a user's body in need of pain treatment. The topical composition may include a topical analgesic and an absorbent, wherein the topical composition is substantially free of volatile alcohol.

[0019] According to one example, a method of relieving pain in a user with sensitive skin includes topically applying a composition comprising lidocaine and colloidal oatmeal to an external skin portion of a user's body in need of pain treatment, wherein the composition is substantially free of volatile alcohols. According to one example, the amount of lidocaine may be 0.5 wt % to 8 wt %, and the amount of colloidal oatmeal may be 0.1 wt % to 5 wt %. DETAILED DESCRIPTION

[0020] It is believed that one skilled in the art can utilize the present invention to its fullest extent based on the description herein.The following specific examples should be construed as merely illustrative and not limiting of the remainder of the present disclosure in any way whatsoever.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, all publications, patent applications, patents and other references mentioned herein are incorporated by reference.

[0022] Unless otherwise indicated, percentages used to express the amount of an ingredient are weight percentages (referred to as "weight %", "wt %, "wt. %, "weight %" or "% (W / W)"). Similarly, weight ratios used to express the relative proportions of ingredients are also determined using weight percentages (i.e., the weight ratio is calculated by dividing the weight percentage of one ingredient by the weight percentage of another ingredient). Unless otherwise stated, all ranges are inclusive, e.g., "4 to 9" includes the endpoints 4 and 9.

[0023] As used herein, "product" is optionally in the form of finished product packaging. In one example, the packaging is a container containing the composition, such as a plastic, metal or glass tube or can. In one example, the composition can be squeezed or pumped out of the container. In another example, an applicator (such as a roller, a roller ball, a brush, a massage element or other functional applicator) can be used to apply the composition to the skin. According to another example, the composition may not be suitable for a spray or aerosol dispensing system. The product may also contain additional packaging, such as a plastic or cardboard box for storing such containers. In one example, the product comprises the composition of the present invention and contains instructions for instructing the user to apply the composition to the skin.

[0024] As used herein, "topical application" means applying or rubbing directly to the outer layers of the skin by hand or with an applicator such as a wipe, roller, or spray.

[0025] As used herein, "topical composition" means a composition that is applied to the outer layer of the skin of a user.

[0026] As used herein, "pain relief" refers to the relief of pain at one or more locations in the body.

[0027] As used herein, "cosmetically acceptable" means that the ingredients described by the term are suitable for use in contact with tissue (eg, skin or hair) without undue toxicity, incompatibility, instability, irritation, allergic response, and the like.

[0028] As used herein, the term "safe and effective amount" means an amount sufficient to cause the desired effect but low enough to avoid serious side effects. The safe and effective amount of a compound, extract or composition will vary with factors such as the age, health and environmental exposure of the end user, the duration and nature of the treatment, the specific extract, ingredient or composition employed, and the specific carrier used.

[0029] As used herein, the term "about" means within 5 weight %, within 4 weight %, within 3 weight %, within 2.5 weight %, within 2 weight %, or within 1 weight % of the disclosed value.

[0030] One aspect of the present invention relates to a topical composition for pain relief, which is suitable for users or consumers with sensitive skin. The topical composition comprises a topical analgesic and a volatile emollient and / or absorbent; and the topical composition is substantially free of volatile alcohol.

[0031] In particular, it has been surprisingly found that volatile emollients, particularly isododecane, are sufficient to provide a sufficiently mild cooling sensation to sensitive skin users suffering from body pain. Accordingly, another aspect of the present invention relates to a method of providing a cooling sensation to the sensitive skin of a user suffering from body pain, the method comprising applying to the sensitive skin a composition comprising a topical analgesic and isododecane.

[0032] Furthermore, it has been surprisingly found that absorbents, particularly colloidal oatmeal (also known as Avena Sativa kernel flour), provide a gentle experience for sensitive skin users suffering from body aches. Accordingly, another aspect of the present invention relates to a method of providing gentle pain relief to users suffering from sensitive skin and body aches, the method comprising applying a composition comprising a topical analgesic and colloidal oatmeal to sensitive skin.

[0033] As used herein, "analgesics" means a class of drugs designed to relieve pain without causing loss of consciousness. Such analgesics may be over-the-counter (OTC) or prescription drugs. Examples of analgesics may include, for example, acetaminophen, aspirin, COX inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs).

[0034] "Topical analgesics" refer to drugs, medicaments or pain relievers applied to the skin to relieve muscle, joint or nerve pain. In some cases, topical analgesics can also be classified as anti-irritants or anti-inflammatory agents. Topical analgesics can be absorbed by the skin and can act on subcutaneous tissue. Examples of suitable topical analgesics can include lidocaine, capsaicin, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylic acid rubefacients, benzocaine, tetracaine, nitroglycerin, rubefacients such as camphor, menthol, methyl nicotinate and methyl salicylate, and salicylates such as aspirin, magnesium salicylate and sodium salicylate. For example, capsaicin, menthol, methyl salicylate and camphor can also be classified as anti-irritants. Topical analgesics can include combinations of those listed above.

[0035] According to one example, an analgesic or topical analgesic may be recommended for external application to the skin, also referred to as an "external skin portion" of the user's body. For example, a topical analgesic should not be applied to internal body surfaces, such as the oral cavity. Thus, the term "topical analgesic" may be used in addition to or in place of "topical analgesic."

[0036] The analgesic or topical analgesic may be present in an amount ranging from about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 4.5%, or 5% to about 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.5%, or 5% by weight of the total composition. .6 wt %, 3.7 wt %, 3.8 wt %, 3.9 wt %, 4 wt %, 4.1 wt %, 4.2 wt %, 4.3 wt %, 4.4 wt %, 4.5 wt %, 4.6 wt %, 4.7 wt %, 4.8 wt %, 4.9 wt %, 5 wt %, 5.5 wt %, 6 wt %, 6.5 wt %, 7 wt %, 7.5 wt %, 8 wt %, 8.5 wt %, 9 wt %, 10 wt %. In one or more examples, the analgesic or topical analgesic is present in an amount ranging from about 0.1 wt % to about 10 wt % by the total weight of the composition. In some examples, the analgesic or topical analgesic is present in an amount ranging from about 0.5 wt % to about 8 wt % by the total weight of the composition. In one or more examples, the analgesic or topical analgesic is present in an amount ranging from about 2 wt % to about 6 wt % by the total weight of the composition. In some examples, the analgesic or topical analgesic is present in an amount ranging from about 3% to about 5% by weight based on the total weight of the composition. In one or more examples, the analgesic or topical analgesic is present in an amount ranging from about 3.5% to about 4.5% by weight based on the total weight of the composition. In some examples, the analgesic or topical analgesic is present in an amount of about 4% by weight based on the total weight of the composition.

[0037] In one or more examples, the topical analgesic includes lidocaine and is present in an amount ranging from about 0.1% by weight to about 10% by weight based on the total weight of the composition. In some examples, lidocaine is present in an amount ranging from about 0.5% by weight to about 8% by weight based on the total weight of the composition. In one or more examples, lidocaine is present in an amount ranging from about 2% by weight to about 6% by weight based on the total weight of the composition. In some examples, lidocaine is present in an amount ranging from about 3% by weight to about 5% by weight based on the total weight of the composition. In one or more examples, lidocaine is present in an amount ranging from about 3.5% by weight to about 4.5% by weight based on the total weight of the composition. In some examples, lidocaine is present in an amount ranging from about 4% by weight based on the total weight of the composition.

[0038] As used herein, "volatile emollient" refers to an emollient having a flash point within 15 ° C of the skin temperature, and therefore does not persist on the skin after application. Volatile emollients can act as cooling agents to provide a cooling sensation to the user's skin and will evaporate easily. Although it is not desired to be bound by any particular theory, it is believed that volatile emollients provide a cooling sensation on the skin only due to the evaporation of ingredients from the skin. It is believed that when the time required for the evaporation of ingredients is longer, there is a higher cooling effect. According to one or more examples, the composition may include a volatile emollient, such as isododecane. Other examples of volatile emollients may include cyclopentasiloxane, dimethicone, isoparaffin fractions (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl polymethicone. In some examples, the volatile emollient includes isododecane.

[0039] The volatile emollient may be present in an amount ranging from about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 5%, or 6% to about 3.6% by weight of the total composition. 5 weight%, 3.6 weight%, 3.7 weight%, 3.8 weight%, 3.9 weight%, 4 weight%, 4.1 weight%, 4.2 weight%, 4.3 weight%, 4.4 weight%, 4.5 weight%, 4.6 weight%, 4.7 weight%, 4.8 weight%, 4.9 weight%, 5 weight%, 5.5 weight%, 6 weight%, 6.5 weight%, 7 weight%, 7.5 weight%, 8 weight%, 8.5 weight%, 9 weight%, 10 weight%, 11 weight%, 12 weight%. In another example, the volatile emollient can be present in an amount ranging from about 0.1%, 0.5%, 1%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%, 8% by weight of the total composition. %, 8.1 wt %, 8.2 wt %, 8.3 wt %, 8.4 wt %, 8.5 wt % or 9 wt % to about 7.5 wt %, 7.6 wt %, 7.7 wt %, 7.8 wt %, 7.9 wt %, 8 wt %, 8.1 wt %, 8.2 wt %, 8.3 wt %, 8.4 wt %, 8.5 wt %, 8.6 wt %, 8.7 wt %, 8.8 wt %, 8.9 wt %, 9 wt %, 9.5 wt %, 10 wt %, 11 wt %, 12 wt %. In one or more examples, the volatile emollient is present in an amount in the range of about 0.1 wt % to about 12 wt % by the total weight of the composition. In some examples, the volatile emollient is present in an amount in the range of about 1 wt % to about 12 wt % by the total weight of the composition. In one or more examples, the volatile emollient is present in an amount in the range of about 2 wt % to about 10 wt % by the total weight of the composition. In some examples, the volatile emollient is present in an amount ranging from about 3 wt % to about 9 wt % by the total weight of the composition. In one or more examples, the volatile emollient is present in an amount ranging from about 3.5 wt % to about 8.5 wt % by the total weight of the composition. In some examples, the volatile emollient is present in an amount ranging from about 4 wt % to about 8 wt % by the total weight of the composition.In one or more examples, the volatile emollient is present in an amount of about 4 wt % based on the total weight of the composition. In some examples, the volatile emollient is present in an amount of about 8 wt % based on the total weight of the composition.

[0040] In one or more examples, the volatile emollient includes isododecane. The isododecane can be present in an amount ranging from about 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 5%, or 6% by weight of the total composition. %, 3.6 wt%, 3.7 wt%, 3.8 wt%, 3.9 wt%, 4 wt%, 4.1 wt%, 4.2 wt%, 4.3 wt%, 4.4 wt%, 4.5 wt%, 4.6 wt%, 4.7 wt%, 4.8 wt%, 4.9 wt%, 5 wt%, 5.5 wt%, 6 wt%, 6.5 wt%, 7 wt%, 7.5 wt%, 8 wt%, 8.5 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%. In another example, isododecane can be present in an amount ranging from about 0.1 wt %, 0.5 wt %, 1 wt %, 2 wt %, 2.5 wt %, 3 wt %, 3.5 wt %, 4 wt %, 4.5 wt %, 5 wt %, 5.5 wt %, 6 wt %, 6.5 wt %, 7 wt %, 7.1 wt %, 7.2 wt %, 7.3 wt %, 7.4 wt %, 7.5 wt %, 7.6 wt %, 7.7 wt %, 7.8 wt %, 7.9 wt %, 8 wt %, 9 wt %, 10 wt %, 11 wt %, 12 wt %, 13 wt %, 14 wt %, 15 wt %, 16 wt %, 17 wt %, 18 wt %, 19 wt %, 20 wt %, 21 wt %, 22 wt %, 23 wt %, 24 wt %, 25 wt %, 26 wt %, 27 wt %, 28 wt %, 29 wt %, 30 wt %, 31 wt %, 32 %, 8.1 wt %, 8.2 wt %, 8.3 wt %, 8.4 wt %, 8.5 wt % or 9 wt % to about 7.5 wt %, 7.6 wt %, 7.7 wt %, 7.8 wt %, 7.9 wt %, 8 wt %, 8.1 wt %, 8.2 wt %, 8.3 wt %, 8.4 wt %, 8.5 wt %, 8.6 wt %, 8.7 wt %, 8.8 wt %, 8.9 wt %, 9 wt %, 9.5 wt %, 10 wt %, 11 wt %, 12 wt %. In one or more examples, isododecane is present in an amount ranging from about 0.1 wt % to about 12 wt % by the total weight of the composition. In some examples, isododecane is present in an amount ranging from about 1 wt % to about 12 wt % by the total weight of the composition. In one or more examples, isododecane is present in an amount ranging from about 2 wt % to about 10 wt % by the total weight of the composition. In some examples, isododecane is present in an amount ranging from about 3 wt % to about 9 wt % based on the total weight of the composition. In one or more examples, isododecane is present in an amount ranging from about 3.5 wt % to about 8.5 wt % based on the total weight of the composition. In some examples, isododecane is present in an amount ranging from about 4 wt % to about 8 wt % based on the total weight of the composition.In one or more examples, isododecane is present in an amount of about 4 wt % based on the total weight of the composition. In some examples, isododecane is present in an amount of about 8 wt % based on the total weight of the composition.

[0041] As used herein, an "absorbent" is an ingredient that has the ability to absorb or imbibe liquids. According to one example, the absorbent may be a "processed oat ingredient," which refers to an ingredient that is typically derived from a portion of the oat plant (avena sativa). Processed oat ingredients are known to have antioxidant, antifungal, and anti-inflammatory properties. Processed oat ingredients have been shown to be effective in treating sensitive skin, including dry, rough, flaky, and itchy skin. In powder form, processed oat ingredients can also absorb oil and may be beneficial for those with oily skin.

[0042] Processed oat ingredients can be processed (e.g., extracted, ground, fermented) from one or more parts of the oat plant (e.g., grains, leaves, stems, seeds), or can be molecules found in the oat plant (e.g., β-glucans, flavonoids, avenamides, lipids, peptides, etc.). The definition is intended to encompass processed oat ingredients derived from sources other than oats (e.g., from another plant or chemically synthesized) but otherwise related to oats. In one or more examples, the processed oat ingredient is selected from oat extract, colloidal oat, colloidal oat flour, oat flour, oat bran, oat protein, oat peptides, oat oil, fermented oats, avenamides, β-glucans, modified oat grain materials (e.g., chemically modified, enzymatically modified, microbially modified), and combinations thereof.

[0043] As used herein, "colloidal oatmeal flour" or "colloidal oatmeal" means a powder obtained by grinding and further processing whole oat kernels that meets the standards of U.S. No. 1 or No. 2 oats. Colloidal oatmeal flour has a particle size distribution in which no more than 3% of the total particles exceed 150 microns in size, and no more than 20% of the total particles exceed 75 microns in size. Examples of suitable colloidal oatmeal flours include, but are not limited to, "Tech-0" available from Beacon Corporation and colloidal oatmeal flour available from Quaker.

[0044] The processed oat component can be present in an amount ranging from about 0.01%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 81%, 82%, %, 4.5 wt % or 5 wt % to about 0.5 wt %, 0.6 wt %, 0.7 wt %, 0.8 wt %, 0.9 wt %, 1 wt %, 1.1 wt %, 1.2 wt %, 1.3 wt %, 1.4 wt %, 1.5 wt %, 1.6 wt %, 1.7 wt %, 1.8 wt %, 1.9 wt %, 2 wt %, 2.5 wt %, 3 wt %, 3.5 wt %, 4 wt %, 5 wt %, 6 wt %, 7 wt %, 8 wt %, 9 wt %, 10 wt %. In one or more examples, the processed oat component is present in an amount in the range of about 0.1 wt % to about 10 wt % by the total weight of the composition. In some examples, the processed oat component is present in an amount in the range of about 0.1 wt % to about 5 wt % by the total weight of the composition. In one or more examples, the processed oat component is present in an amount in the range of about 0.5 wt % to about 5 wt % by the total weight of the composition. In some examples, the processed oat component is present in an amount in the range of about 0.5% by weight to about 4% by weight by the total weight of the composition. In one or more examples, the processed oat component is present in an amount in the range of about 0.5% by weight to about 3% by weight by the total weight of the composition. In some examples, the processed oat component is present in an amount in the range of about 0.5% by weight to about 2.5% by weight by the total weight of the composition. In one or more examples, the processed oat component is present in an amount in the range of about 0.5% by weight to about 1.5% by weight by the total weight of the composition. In some examples, the processed oat component is present in an amount of about 1% by weight by the total weight of the composition.

[0045] In one or more examples, the processed oatmeal ingredients include colloidal oatmeal powder, and about 0.1% to about 10% by weight by the total weight of the composition. In some examples, colloidal oatmeal powder is about 0.1% to about 5% by weight by the total weight of the composition. In one or more examples, colloidal oatmeal powder is about 0.5% to about 5% by weight by the total weight of the composition. In some examples, colloidal oatmeal powder is about 0.5% to about 4% by weight by the total weight of the composition. In one or more examples, colloidal oatmeal powder is about 0.5% to about 3% by weight by the total weight of the composition. In some examples, colloidal oatmeal powder is about 0.5% to about 2.5% by weight by the total weight of the composition. In one or more examples, colloidal oatmeal powder is present in an amount of about 0.5% to about 1.5% by weight by the total weight of the composition. In some examples, colloidal oatmeal powder is present in an amount of about 1% by weight by the total weight of the composition.

[0046] According to one example, the composition may also not include certain ingredients. The term "substantially free" means that the composition has less than 5 wt%, less than 4 wt%, less than 3 wt%, less than 2 wt%, less than 1 wt%, less than 0.75 wt%, or less than 0.5 wt% of a particular ingredient. The term "completely free" means that the composition has less than 0.5 wt%, less than 0.4 wt%, less than 0.3 wt%, less than 0.2 wt%, less than 0.1 wt% of a component or is completely free of the component.

[0047] According to one example, the composition may be substantially free of volatile alcohols. The term "volatile alcohol" refers to an alcohol that evaporates easily, or an alcohol whose vapor pressure is higher than the vapor pressure of water at 20°C. According to another example, the composition may be completely free of volatile alcohols. Examples of volatile alcohols include, but are not limited to, specially denatured (SD) alcohols, such as SD alcohol 40, denatured alcohol, ethanol, methanol, and isopropanol. The vapor pressures of various alcohols at 20°C include ethanol with a vapor pressure of 5.95 kPa (kilopascals), methanol with a vapor pressure of 11.9 kPa, and isopropanol with a vapor pressure of 4.40 kPa.

[0048] According to one example, the composition may be substantially free of or completely free of a cooling agent such as menthol, or a cooling sensation agent such as menthyl esters such as lactic acid menthol. Other examples of cooling agents may include menthyl glutarate, N-ethyl 2-isopropyl-5-methylcyclohexane carboxamide, N-[(ethoxycarbonyl)methyl)-p-menthane-3-carboxamide and (1R, 2S, 5R)-N-(4-methoxyphenyl)-5-methyl-2-(1-methylethyl) cyclohexane carboxamide. Cooling agents may include benzene rings and polar side groups, such as menthyl glutarate. In some examples, more than one combination of coolants including benzene rings with polar side groups may be used as a cooling agent. In one example, a combination of a cooling agent including a benzene ring with a polar side group and a cooling agent not including a benzene ring with a polar side group may be used as a cooling agent. In another example, the coolant including a benzene ring with polar side groups is a coolant having a cyclohexyl core substituted at ring positions 1, 3, and 4 and an ester or amide group substituted at one of these three positions.

[0049] The composition may include one or more "thickeners" or "viscosifiers" selected from, for example, ammonium acryloyldimethyltaurate / vinyl pyrrolidone copolymer, sodium acryloyldimethyltaurate / vinyl pyrrolidone copolymer, sodium polyacrylate, carbomer and / or acrylate copolymers. According to one example, the composition may include from about 0.1% to about 10% by weight, or from about 0.5% to about 5% by weight, or from about 1% to 4% by weight of thickener. The amount and selection of thickener allows the cream or gel cream to be stable while maintaining the aesthetics and skin feel of the cream or gel cream.

[0050] In one example, the composition can include about 0.1 wt % to about 0.8 wt % of carbomer and about 0.5 wt % to about 1.0 wt % of sodium polyacrylate. The composition can, for example, include about 0.4 wt % of carbomer and about 0.75 wt % of sodium polyacrylate.

[0051] In another example, the composition may include about 0.1 wt % to about 0.8 wt % of carbomer, about 0.4 wt % to about 1.0 wt % of sodium polyacrylate, and about 1.0 wt % to about 3.0 wt % of acrylate copolymer. The composition may, for example, include about 0.4 wt % of carbomer, about 0.6 wt % of sodium polyacrylate, and about 2.0 wt % of acrylate copolymer.

[0052] As used herein, the term "emulsifier" refers to an ingredient that helps prevent ingredients (such as oil and water) from separating in an emulsion. According to one example, an example of an emulsifier may include cetyl alcohol. According to one example, the composition may include about 0.1% by weight to about 10% by weight, or about 1% by weight to about 6% by weight, or about 2.5% by weight to 4.5% by weight of an emulsifier. In one example, the emulsifier may be about 3% by weight.

[0053] The compositions of the present invention are applied topically to human skin. Thus, the compositions may also contain cosmetically acceptable topical ingredients known in the personal care art for use with oil-in-water emulsion cream formulations or gel cream formulations.

[0054] The composition may contain, for example, suitable gelling agents such as natural gums, acrylic acid and acrylate polymers and copolymers, and cellulose derivatives (e.g., hydroxymethylcellulose and hydroxypropylcellulose). Suitable gelling agents for oils such as mineral oils include, but are not limited to, hydrogenated butylene / ethylene / styrene copolymers and hydrogenated ethylene / propylene / styrene copolymers. Such gels typically contain from about 0.1% to 5% by weight of such gelling agents.

[0055] The compositions of the present invention may also contain any of a variety of additional cosmetic active agents. Examples of suitable additional active agents may include: antimicrobial agents, antifungal agents and antibacterial agents, anti-inflammatory agents, additional topical analgesics, sunscreens, photoprotectants, antioxidants, moisturizers, nutrients, vitamins, energy enhancers, hydration enhancers, efficacy enhancers, skin conditioning agents, odor control agents such as odor masking agents or pH modifiers, etc.

[0056] The additional cosmetic active agent can be present in the composition in any suitable amount, for example, from about 0.0001% to about 20%, for example, from about 0.001% to about 10%, such as from about 0.01% to about 5%, by weight of the composition. In certain preferred examples, the amount is 0.1% to 5%, and in other preferred examples, the amount is 1% to 2%.

[0057] As used herein, "skin conditioner" generally refers to an ingredient that improves the appearance of dry or damaged skin by reducing scaling and / or restoring softness. For example, a skin conditioner can act as a lubricant on the surface of the skin to give the skin a soft and smooth appearance. Alternatively, a skin conditioner can increase the moisture content of the top layer of the skin by drawing moisture from the surrounding air. In some examples, the composition can include at least one skin conditioner. In one example, the composition can include Zingiber officinale (ginger) root extract, caprylyl glycol, 1,2-hexanediol, and / or tropolone.

[0058] The compositions of the present invention may contain a cosmetically effective amount of one or more skin conditioning agents, such as those described above. Based on active material, the composition preferably contains from about 0.1% to about 10% by weight of a skin conditioning agent, more preferably from about 0.5% to about 5% of a skin conditioning agent, and most preferably from about 0.5% to about 2% of a skin conditioning agent.

[0059] In one example, the composition may include caprylyl glycol in an amount of about 0.1% to about 0.5% by weight and a combination of 1,2-hexanediol, caprylyl glycol, and tropolone in an amount of about 0.1% to about 1.0% by weight. The composition may include caprylyl glycol in an amount of about 0.26% by weight and a combination of 1,2-hexanediol, caprylyl glycol, and tropolone in an amount of about 0.5%. The composition may also include Zingiber officinale (ginger) root extract in an amount of about 0.1% to about 0.3%, such as about 0.2% by weight.

[0060] The compositions of the present invention may contain a cosmetically effective amount of one or more anti-inflammatory compounds. Examples of suitable anti-inflammatory agents may include substituted resorcinols, (E)-3-(4-methylbenzenesulfonyl)-2-acrylonitrile (such as "Bay 11-7082" commercially available from Sigma-Aldrich, St. Louis, Missouri), tetrahydrocurcumin (such as tetrahydrocurcumin CG commercially available from Sabinsa Corporation, Piscataway, NJ), extracts and materials obtained from: Phellodendron amurense cortex extract (PCE), non-denatured soybeans (Glycine max), feverfew (Tanacetum parthenium), ginger (Zingiber officinale), Ginkgo biloba, madecassoside (a component of Centella asiatica extract), Cotinus coggygria, Petasites extract (Petasites hybridus), goji berry (Lycium barbarum), milk thistle extract (Silybum marianum), honeysuckle (Lonicerajaponica), Peruvian balsam (Myroxylon pereirae), sage (Salvia officinalis), cranberry extract (Vaccinium oxycoccos), amaranth oil (Amaranthus cruentus), pomegranate (Punica granatum), yerba mate (Ilex paraguariensis leaf extract), white lily flower extract (Lilium candidum), olive leaf extract (Olea europaea), phloretin (apple extract), oatmeal (Aveena sativa), Lifenol (hops: Humulus lupulus) extract, Bugran P (Ononis spinosa), licorice chalcone (licorice: Glycyrrhiza inflate extract component), Symrelief (bisabolol and ginger extract), a combination of two or more thereof, and the like.

[0061] In certain examples, the composition may include an anti-inflammatory compound in an amount of about 0.5% to about 2% by weight, more preferably about 0.5% to about 1.5%. In another example, the anti-inflammatory compound may include colloidal oatmeal and / or ginger.

[0062] The pH of the composition can be adjusted using a pH adjusting agent commonly used in the art. In one or more examples, the composition has a pH of about 4.5 to about 5.5. In some examples, the pH of the composition ranges from about 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8 or 3.9 to about 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 or 5. In some examples, the pH of the composition ranges from about 3 to about 5 or from about 3.5 to about 4.5. In other examples, the pH of the composition can range from about 6, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, or 6.9 to about 6.8, 6.9, 7, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, or 8. In some examples, the pH of the composition ranges from about 6 to about 7.

[0063] In one example, the pH adjuster can be citric acid in an amount of about 0.1 wt % to about 10 wt %, more preferably about 0.5 wt % to about 5 wt %, and most preferably about 0.5 wt % to about 1 wt %. According to one example, the amount of citric acid can be about 0.6 wt %.

[0064] Various other materials may optionally be present in the composition of the present invention. In certain preferred examples, the composition comprises one or more topical ingredients selected from the group consisting of surfactants, chelating agents, additional emollients, humectants, conditioning agents, preservatives, sunscreens, fragrances, and the like.

[0065] "Emollients" may include compounds that help maintain the soft, smooth and pliable appearance of the skin (e.g., by being retained on the skin surface or in the stratum corneum to act as a lubricant). Examples of suitable emollients include, but are not limited to, petrolatum, isopropyl palmitate, cetyl olive oil esters, sorbitan olive oil esters, candelilla wax, isododecane, hexyl decyl stearate, and vegetable oils, nut oils and vegetable oils and hydrogenated vegetable oils, such as macadamia oil, rice bran oil, grape seed oil, palm oil, primrose oil, hydrogenated peanut oil and avocado oil. According to one example, an emollient may include isopropyl palmitate, cetyl olive oil esters, sorbitan olive oil esters, candelilla wax, hydrogenated vegetable oils, vegetable oils, and combinations thereof.

[0066] In some examples, the composition may include an emollient in an amount of about 0.1 wt % to about 15 wt %, and more preferably about 4 wt % to about 11 wt %, about 7 wt % to about 10 wt %, or about 8 wt % to about 9 wt %. According to one example, the emollient is about 8.5 wt %.

[0067] In one example, the composition may include isopropyl palmitate in an amount of about 4.0% to about 7.0% by weight, a combination of olive oil cetyl alcohol esters and olive oil sorbitan esters in an amount of about 0.1% to about 1.0% by weight, cetyl alcohol in an amount of about 0.1% to about 5.0% by weight, and a combination of candelilla wax, hydrogenated vegetable oil, and vegetable oil in an amount of about 1.0% to about 5.0% by weight. The composition may include isopropyl palmitate in an amount of about 5.0% by weight, a combination of olive oil cetyl alcohol esters and olive oil sorbitan esters in an amount of about 0.5% by weight, cetyl alcohol in an amount of about 1.0% by weight, and a combination of candelilla wax, hydrogenated vegetable oil, and vegetable oil in an amount of about 2.0% by weight. In another example, the composition may include isopropyl palmitate in an amount of about 5.0 weight %, a combination of cetyl olive oil esters and sorbitan olive oil esters in an amount of about 0.5 weight %, cetyl alcohol in an amount of about 3.0 weight %, and a combination of candelilla wax, hydrogenated vegetable oil, and vegetable oil in an amount of about 3.0 weight %.

[0068] In another example, the composition can further include isododecane as a volatile emollient in an amount of about 1.0 wt % to about 12.0 wt %, such as about 4.0 wt % or about 8.0 wt %. The composition can also exclude isododecane.

[0069] As used herein, "oil" means an organic hydrophobic compound that is liquid at 25° C., excluding silicone-based materials. Examples of organic oils include various hydrocarbons (straight or branched alkanes or alkenes, ketones, diketones, primary or secondary alcohols, aldehydes, sterol esters, alkanoic acids, turpenes, monoesters), such as those with carbon chain lengths ranging from C6-C38 (such as C6-C18).

[0070] Specific non-limiting examples of oils include, but are not limited to, natural oils such as castor oil, mineral oil, triglycerides, esters of alcohols (glycerol or other than glycerol, including diesters or other branched esters) with fatty acids or fatty alcohols, and various natural waxes, including shea butter (butea butter), lotus wax; beeswax, insect waxes, sperm whale oil, lanolin, vegetable waxes such as carnauba wax, jojoba oil, candelilla wax; mineral waxes such as paraffin; and synthetic waxes such as cetyl palmitate, lauryl palmitate, cetearyl stearate, and polyethylene wax.

[0071] The oil may include, for example, esters such as isopropyl palmitate, isopropyl myristate, isononyl isononanoate (such as WICKENOL 151 available from Alzo Inc. of Sayreville, NJ), C12-C15 alkyl benzoates (such as FINSOLV TN from Innospec Active Chemicals), caprylic / capric triglyceride, pentaerythritol tetracaprylate, mineral oil, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoate, PPG-2-myristyl ether propionate, ethyl methicone, and diethylhexyl cyclohexane. Additional examples of oils include functional oils such as vitamin E acetate.

[0072] "Humectant" means a compound intended to increase the moisture content of the surface layer of the skin (e.g., a hygroscopic compound). Examples of suitable humectants include, but are not limited to, glycerol, sorbitol, or trehalose (e.g., α,α-trehalose, β,β-trehalose, α,β-trehalose) or a salt or ester thereof (e.g., trehalose 6-phosphate). In one example, the humectant is glycerol (also spelled interchangeably as "glycerol").

[0073] In some examples, the composition may include a wetting agent in an amount of about 1% to about 20% by weight, more preferably about 10% to about 15%. According to one example, the wetting agent is about 12% by weight. According to another example, the wetting agent is about 14% by weight.

[0074] As used herein, "preservative" refers to an ingredient that can prevent or slow bacterial growth and thus protect the cosmetic from spoiling. Suitable preservatives include, for example, caprylyl glycol, 1,2-hexanediol, tropolone and / or chlorphenesin, and are present in the composition in an amount of about 0% to about 5% or about 0.05% to about 2%, based on the total weight of the composition. According to one example, the preservative is present in an amount of about 0.56% by weight.

[0075] In one example, the composition may include a caprylyl glycol preservative in an amount of about 0.1 wt % to about 0.5 wt % and a chlorphenesin preservative in an amount of about 0.1 wt % to about 0.5 wt %. The composition may include a caprylyl glycol preservative in an amount of about 0.26 wt % and a chlorphenesin preservative in an amount of about 0.3 wt %.

[0076] Any of a variety of commercially available pearlescent or opacifying agents are suitable for use in the composition. Examples of suitable pearlescent or opacifying agents include, but are not limited to, monoesters or diesters of: (a) a fatty acid having from about 16 to about 22 carbon atoms and (b) ethylene or propylene glycol; (a) a fatty acid having from about 16 to about 22 carbon atoms and (b) a compound of the formula: HO-(JO) a-H, wherein J is an alkylene group having from about 2 to about 3 carbon atoms; and a is 2 or 3; a fatty alcohol containing from about 16 to about 22 carbon atoms; a fatty acid ester of the formula: KCOOCH2L, wherein K and L independently contain from about 15 to about 21 carbon atoms; an inorganic solid insoluble in the composition; and mixtures thereof.

[0077] Any fragrance composition suitable for use on the skin may be used according to the present invention.The amount of fragrance may be from 0.1 wt% to 2 wt%.

[0078] According to one example, the composition may contain water, such as purified water, to serve as a vehicle. Depending on the form of the product, water may be added in an amount of about 50% to about 95% by weight of the composition, as discussed below. Water may be added to achieve a sufficient amount ("qs" or "QS") in the formulation.

[0079] Product form and packaging

[0080] A variety of product forms and packaging may be applicable to any of the compositions described herein. As described above, a "product" is optionally in the form of a finished product package. In one example, the package is a container containing the composition, such as a plastic, metal or glass tube or can. In one or more examples, the composition can be squeezed or pumped out of the container. The product may also contain additional packaging, such as a plastic or cardboard box for storing such a container. In one or more examples, the product comprises the composition of the present invention and contains instructions for instructing the user to apply the composition to the skin.

[0081] Any of the compositions that can be in the form of an emulsion, including but not limited to oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions, can be used herein. These emulsions can cover a range of viscosities, for example, from about 100 cps to about 200,000 cps. Two types of viscosity measurements are mentioned in this application: A) "rheometer viscosity", which is measured at 25°C in a rheometer at 20 s -1 The viscosity of the rheometer is the steady state value measured at an applied shear rate of 1000 rpm and B) the "Brookfield viscosity" measured after 1 minute at 25°C in a 4 ounce jar using spindle RV#4 or RV#5 at 5 RPM or 10 RPM. Unless otherwise stated, the viscosity mentioned is the rheometer viscosity.

[0082] In one or more examples, the compositions described herein may be in the form of lotions, gels, creams, or gel-cream products. Lotions, gels, creams, and gel-cream products may advantageously have properties that allow the composition to flow and be applied to the skin. Such products are typically thin enough to allow volatile emollients to evaporate and provide a cooling effect. If too thick, as with ointments, sealants, or patches, the user may not feel the cooling effect.

[0083] In one or more examples, the compositions described herein are in the form of lotions. As used herein, the term "lotion" means a predominantly aqueous topical preparation having a light texture and a refreshing watery feel, with a viscosity of about 1,000 cPs to 4,000 cPs. In addition to a solvent, a lotion or serum typically includes at least one emollient. The lotion / serum may include about 1% to about 20% (e.g., about 5% to about 10%) of an emollient and about 50% to about 90% (e.g., about 60% to about 80%) of water.

[0084] In one or more examples, the composition described herein is in the form of a cream. As used herein, the term "cream" means a rich, mainly aqueous topical preparation having a viscosity of about 2,000 cPs to 8,000 cPs. Creams typically contain about 5% to about 50% (e.g., about 10% to about 20%) of an emollient and about 45% to about 85% (e.g., about 50% to about 75%) of water.

[0085] Lotions and creams can be formulated as emulsions. Typically such lotions contain 0.5% to about 5% emulsifier, while such creams will typically contain about 1% to about 20% (e.g., about 5% to about 10%) of an emollient; about 20% to about 80% (e.g., 30% to about 70%) of water; and about 1% to about 10% (e.g., about 2% to about 5%) of an emulsifier.

[0086] Oil-in-water and water-in-oil single-phase emulsion skin care formulations (such as lotions and creams) are well known in the art and can be used in the subject invention. Multiphase emulsion compositions, such as water-in-oil-in-water or oil-in-water-in-oil, can also be used in the subject invention. Generally speaking, such single emulsions or multiphase emulsions contain water, emollients and emulsifiers as main ingredients.

[0087] The compositions of the present invention may also be formulated as gels. As used herein, the term "gel" means a rich, predominantly aqueous topical preparation that contains a dispersed polymer and exhibits a yield value of about 0.1 Pa or more. The gel may contain a gelling agent. Such gels typically contain about 0.1% to 5% by weight of such a gelling agent.

[0088] According to another example, the composition of the present invention can be formulated as a gel cream. As used herein, the term "gel cream" means a mainly water-containing topical preparation with a rich texture, which has some user aesthetics of both cream and gel as defined above. The gel cream can have a viscosity of about 2,000 cP to 8,000 cP. The gel cream can contain about 5% to about 50% (e.g., about 10% to about 20%) of an emollient and about 45% to about 85% (e.g., about 50% to about 75%) of water. The gel cream can contain a dispersed polymer and show a yield value of about 0.1 Pa or higher. The gel cream can contain one or more gelling agents, such as about 0.1 wt % to 5 wt % of such gelling agents.

[0089] The compositions of the present invention may also be formulated as solid formulations (eg, wipes). The compositions of the present invention may also be combined with and / or impregnated onto solid, semisolid or dissolvable substrates (eg, wipes, masks, pads, gloves or tapes).

[0090] The compositions described herein can be provided to consumers in containers (e.g., bottles, tubes, etc.). Individual packages enclosing measured portions of the composition can also be used. To dispense the composition from the bottle, a pump, a squeezable valve, or a removable screw cap can be used.

[0091] method

[0092] The present invention also includes a method of relieving pain by topically applying a composition of the present invention to the skin in an area in need of pain relief. The method includes, for example, topically applying the composition to the skin of a location on the body in need of pain relief. Such topical application can be to any skin on the body in need of treatment, such as the skin of the face, neck, chest, back, buttocks, arms, armpits, hands, feet, and / or legs.

[0093] The present invention includes a method of relieving pain by topically applying a composition of the present invention to the skin in an area in need of pain relief, wherein the user or subject has sensitive skin. The method includes, for example, topically applying the composition to sensitive skin at a location on the body in need of pain relief. Such topical application can be to any skin on the body in need of treatment, such as the skin of the face, neck, chest, back, buttocks, arms, armpits, hands, feet, and / or legs.

[0094] The composition can be applied to the skin as needed, or otherwise used at a frequency desired by the user. In one or more examples, the composition is applied once or twice a day.

[0095] Any suitable method of applying the composition to the skin in need can be used. For example, the composition can be applied directly to the skin in need from the package, applied to the skin in need by hand, applied to the skin in need using an applicator, or transferred from a substrate such as a wipe or mask, or a combination of two or more thereof. In other examples, the composition can be applied via a dropper, tube, roller, pump, and patch, or added to a bathtub or otherwise added to water for application to the skin, etc. The composition can be applied in a variety of ways / forms, including but not limited to as a leave-on cream, a rinse-off cream, and / or as part of a patch.

[0096] The compositions and preparations and products containing such compositions can be prepared using methods well known to those of ordinary skill in the art. The compositions can be used routinely and are substantially non-irritating to the skin.

[0097] Example

[0098] The following examples further illustrate embodiments of the present invention. All amounts are given in weight percentages. The present invention is not limited to the embodiments contained therein.

[0099] Example 1: Topical gel cream containing isododecane

[0100] As shown in Table 1, a topical gel cream composition according to an embodiment of the present invention having the following ingredients was prepared.

[0101] Table 1: List of ingredients for Example 1

[0102]

[0103] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0104] 2: Yes SP is commercially available from UL Prospector Corporation

[0105] 3: Commercially available as Radia 7732 from Oleon Corporation

[0106] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0107] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0108] 6: Commercially available as Cegesoft VP from UL Prospector Corporation

[0109] 7: Permethyl 99A is commercially available from Presperse Corporation

[0110] 8: Hydrolite CG is commercially available from Symrise Corporation

[0111] 9: Symdiol 68T is commercially available from Symrise Corporation

[0112] 10: Germazide C is commercially available from BASF Corporation

[0113] The following mixing steps can be used to prepare Example 1:

[0114] a) Add purified water to a suitable container and add colloidal oatmeal while mixing.

[0115] b) While mixing, add citric acid and lidocaine USP and mix until dissolved.

[0116] c) Add the Carbomer while mixing slowly until all lumps are dissolved.

[0117] d) Heat the mixture to 75°C-80°C.

[0118] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0119] f) Then slowly add sodium polyacrylate while mixing at 75°C-80°C until uniform.

[0120] g) The oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) were then added while mixing.

[0121] h) The mixture was mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes.

[0122] i) The mixture was cooled to 25°C and 7% glycerol and isododecane were added and mixed.

[0123] j) Add ginger root extract, 1,2-hexanediol; caprylyl glycol; tropolone and mix until homogeneous.

[0124] k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0125] l) Make up the batch to 95%-100% of the theoretical batch weight with water.

[0126] Example 2: Topical Cream Containing Isododecane

[0127] As shown in Table 2, topical cream compositions according to examples of the present invention were prepared having the following ingredients.

[0128] Table 2: List of ingredients for Example 2

[0129]

[0130]

[0131] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0132] 2: Yes SP is commercially available from UL Prospector Corporation

[0133] 3: Commercially available as Radia 7732 from Oleon Corporation

[0134] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0135] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0136] 6: Cegesoft BP is commercially available from UL Prospector Corporation

[0137] 7: Permethyl 99A is commercially available from Presperse Corporation

[0138] 8: Commercially available as Carbopol Aqua SF-1 polymer from Lubrizol Corporation

[0139] 9: Hydrolite CG is commercially available from Symrise Corporation

[0140] 10: Available commercially as Symdiol 68T from Symrise Corporation

[0141] 11: Germazide C is commercially available from BASF Corporation

[0142] The following mixing steps can be used to prepare Example 2:

[0143] a) Add purified water to a suitable container and add colloidal oatmeal while mixing.

[0144] b) While mixing, add citric acid and lidocaine USP and mix until dissolved.

[0145] c) Add the Carbomer while mixing slowly until all lumps are dissolved.

[0146] d) Heat the mixture to 75°C-80°C.

[0147] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0148] f) Then slowly add sodium polyacrylate while mixing at 75°C-80°C until uniform.

[0149] g) The oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) were then added while mixing.

[0150] h) The mixture was mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes.

[0151] i) The mixture was cooled to 25°C and isododecane was added and mixed.

[0152] j) Add fragrance, 1,2-hexanediol; caprylyl glycol; tropolone and mix until uniform.

[0153] k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0154] l) In a separate container add 5% glycerin and acrylate copolymer and mix until homogeneous to produce acrylate copolymer premix.

[0155] m) Add the acrylate copolymer premix to the mixture from step 11 and mix until uniform.

[0156] Example 3: Topical Gel Cream Without Isododecane

[0157] According to one example, the topical gel cream composition of Example 1 can be reformulated to not include isododecane. For example, as shown in Table 3, a topical gel cream composition according to the present invention having the following ingredients is prepared.

[0158] Table 3: List of ingredients for Example 3

[0159]

[0160] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0161] 2: Yes SP is commercially available from UL Prospector Corporation

[0162] 3: Commercially available as Radia 7732 from Oleon Corporation

[0163] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0164] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0165] 6: Commercially available as Cegesoft VP from UL Prospector Corporation

[0166] 7: Hydrolite CG is commercially available from Symrise Corporation

[0167] 8: Symdiol 68T is commercially available from Symrise Corporation

[0168] 9: Germazide C is commercially available from BASF Corporation

[0169] The following mixing steps can be used for Example 3:

[0170] a) Add purified water to a suitable container and add colloidal oatmeal while mixing.

[0171] b) While mixing, add citric acid and lidocaine USP and mix until dissolved.

[0172] c) Add the Carbomer while mixing slowly until all lumps are dissolved.

[0173] d) Heat the mixture to 75°C-80°C.

[0174] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0175] f) Then slowly add sodium polyacrylate while mixing at 75°C-80°C until uniform.

[0176] g) The oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) were then added while mixing.

[0177] h) The mixture was mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes.

[0178] i) The mixture was cooled to 25°C and 7% glycerol was added and mixed.

[0179] j) Add ginger root extract, 1,2-hexanediol; caprylyl glycol; tropolone and mix until homogeneous.

[0180] k) At 35°C or below, adjust the pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0181] l) Make up the batch to 95%-100% of the theoretical batch weight with water.

[0182] Example 4: Topical Cream Without Isododecane

[0183] According to one example, the topical cream composition of Example 2 can be reformulated to not include isododecane. For example, as shown in Table 4, a topical gel cream composition according to the present invention having the following ingredients is prepared.

[0184] Table 4: List of ingredients for Example 4

[0185]

[0186]

[0187] 1: Commercially available as Ultrez 10 polymer from Lubrizol Corporation

[0188] 2: Yes SP is commercially available from UL Prospector Corporation

[0189] 3: Commercially available as Radia 7732 from Oleon Corporation

[0190] 4: Olivem 1000 is commercially available from Hallstar BPC Corporation

[0191] 5: Vegarol 1698 is commercially available from UL Prospector Corporation

[0192] 6: Cegesoft BP is commercially available from UL Prospector Corporation

[0193] 7: Commercially available as Carbopol Aqua SF-1 polymer from Lubrizol Corporation

[0194] 8: Hydrolite CG is commercially available from Symrise Corporation

[0195] 9: Symdiol 68T is commercially available from Symrise Corporation

[0196] 10: Germazide C is commercially available from BASF Corporation

[0197] The following mixing steps can be used to prepare Example 4:

[0198] a) Add purified water to a suitable container and add colloidal oatmeal while mixing.

[0199] b) While mixing, add citric acid and lidocaine USP and mix until dissolved.

[0200] c) Add the Carbomer while mixing slowly until all lumps are dissolved.

[0201] d) Heat the mixture to 75°C-80°C.

[0202] e) Add caprylyl glycol and chlorphenesin while mixing and mix until uniform

[0203] f) Then slowly add sodium polyacrylate while mixing at 75°C-80°C until uniform.

[0204] g) The oil phase ingredients (7% glycerin, isopropyl palmitate, cetyl olive oil esters; sorbitan olive oil esters and cetyl alcohol) were then added while mixing.

[0205] h) The mixture was mixed for 10 minutes and then homogenized at 5000 RPM for 3 minutes.

[0206] i) The mixture was cooled to 25°C and the fragrance, 1,2-hexanediol; caprylyl glycol; tropolone were added and mixed until homogeneous.

[0207] j) At 35°C or below, adjust pH to 6.5 using sodium hydroxide solution or citric acid solution and mix.

[0208] k) In a separate container add 5% glycerin and acrylate copolymer and mix until homogeneous to produce acrylate copolymer premix.

[0209] 1) Add the acrylate copolymer premix to the mixture from step 11 and mix until uniform.

[0210] Human Use Studies

[0211] Study plan and objectives :

[0212] A human use test (abbreviated as "HUT") was conducted in which 253 consumers (also referred to as "subjects", "patients" or "users") self-applied the formulations in Examples 1 and 2 (also referred to as "formulations" or "products" in this example) as needed for a period of two weeks. These consumers were between 30 and 55 years old, they regularly or occasionally experienced minor aches and pains in muscles or joints, and they had a range of skin tones and types, some of whom reported having sensitive skin, dry skin and / or eczema.

[0213] Consumers were instructed to use the product within the first two days of receipt and then at least once a week as needed over the next two weeks. Consumers were further instructed to abstain from other pain relief treatments during the two-week period. Consumers provided feedback via an online survey at three time points: 1) after first use, 2) after one week of use, and 3) after two weeks of use.

[0214] Example 1 may be referred to as a "calming gel cream" incorporating, for example, ginger, and Example 2 may be referred to as a "calming cream" incorporating a suitable calming fragrance, such as lavender.

[0215] The purpose of human use studies is to provide support for potential consumer perception claims centered on the consumer's experience with the product. For example, one purpose is to understand the consumer's experience with a product regarding absorption, concealment, and skin feel.

[0216] Regarding feel, consumers provide feedback on whether the product feels mild and whether the product makes their skin feel moisturized and / or smooth.

[0217] A "test statement" may be a question or a statement of agreement or disagreement answered by the consumer at least once during the duration of the HUT. According to one example, the following test statement may relate to the consumer's experience with product absorption: fast absorption, immediate absorption into the skin, non-greasy and / or does not make the skin shiny. According to one example, the following test statement may relate to the consumer's experience with "hiddenness": light texture, no irritating taste / smell, no unpleasant taste / smell, non-sticky, non-greasy, does not make the skin shiny, has a pleasant taste. According to one example, the following test statement may relate to the consumer's experience with the feel of the product: light texture, non-sticky, non-greasy, immediately moisturizing, makes the skin feel smooth, immediately cool, feel immediately effective and / or immediately numb. Test statements of immediate cooling, immediate effect and / or immediate numbness may indicate pain relief.

[0218] Results Summary :

[0219] The main data are presented in Table 5 and show the responses described by the consumers, collated as the percentage of users who agreed with the test statements. The overall results and the results for each of Example 1 and Example 2 are shown.

[0220] Table 5: Results of human use studies

[0221]

[0222] *Not applicable: Formulated without fragrance.

[0223] Over 90% of consumers found both Example 1 and Example 2 to be easy to apply, light in texture, and quickly absorbed. Over 90% of consumers also found that Example 1 and Example 2 had no irritating and unpleasant taste / smell. Example 1 appeared to have a better taste perception than Example 2.

[0224] Greater than 60% of consumers also agreed that Examples 1 and 2 were non-sticky, absorbed immediately into the skin, were non-greasy, moisturized immediately, did not leave the skin shiny, had a pleasant scent, felt smooth on the skin, were immediately cooling, and felt immediately effective. Example 2 seemed less sticky than Example 1. Example 2 seemed to provide immediate moisturization faster than Example 1. Example 1 seemed to leave the skin less shiny than Example 2. Example 2 seemed to be immediately cooling faster and felt immediately effective faster than Example 1.

[0225] Approximately 50% of the users agreed that both formulations numbed the skin immediately, however, Example 2 appeared to be more numbing than Example 1.

[0226] It should be understood that while the invention has been described in conjunction with the specific embodiments thereof, the foregoing description is intended to illustrate and not to limit the scope of the invention which is defined by the appended claims. Other aspects, advantages and modifications are within the claims.

Claims

1. A topical composition comprising: a topical analgesic and a volatile emollient, wherein the topical composition is substantially free of volatile alcohol.

2. The topical composition of claim 1, wherein the amount of the topical analgesic is from 0.5% to 8% by weight.

3. The topical composition of claim 1, wherein the topical analgesic is one or more of lidocaine or benzocaine.

4. The topical composition of claim 3, wherein the topical analgesic is lidocaine.

5. The topical composition of claim 4, wherein the amount of lidocaine is about 4% by weight.

6. The topical composition of claim 1, wherein the amount of volatile emollient is from 1 wt% to 12 wt%.

7. The topical composition of claim 1, wherein the volatile emollient is present in an amount of about 4% to about 8% by weight.

8. The topical composition of claim 1, wherein the volatile emollient provides a local cooling sensation.

9. The topical composition of claim 1, wherein the volatile emollient comprises isododecane.

10. The topical composition of claim 1 further comprising an absorbent.

11. The topical composition of claim 10, wherein the absorbent is present in an amount of 0.1 wt% to 5 wt%.

12. The topical composition of claim 10, wherein the absorbent comprises a processed oat ingredient.

13. The topical composition of claim 12, wherein the processed oat ingredient comprises colloidal oatmeal.

14. The topical composition of claim 13, wherein the colloidal oatmeal is present in an amount of about 1% by weight.

15. The topical composition of claim 1, wherein the topical composition is substantially free of menthol and menthol lactate.

16. A method of relieving pain in a user with sensitive skin, the method comprising applying the topical composition of claim 1 to an external skin portion of the user's body in need of pain treatment.

17. A method of relieving pain in a user with sensitive skin, the method comprising topically applying a composition comprising lidocaine and isododecane to an external skin portion of the user's body in need of pain treatment, wherein the composition is substantially free of volatile alcohols.

18. The method of claim 17, wherein the amount of lidocaine is 0.5 wt% to 8 wt%, and wherein the amount of isododecane is 1 wt% to 12 wt%.

19. The method of claim 17, wherein the composition further comprises a processed oat component.

20. The method of claim 19, wherein the amount of the processed oat component is 0.1 wt% to 5 wt%.

21. A topical composition comprising: a topical analgesic and an absorbent, wherein the topical composition is substantially free of volatile alcohol.

22. The topical composition of claim 21, wherein the topical analgesic is present in an amount of 0.5% to 8% by weight.

23. The topical composition of claim 21, wherein the topical analgesic is one or more of lidocaine or benzocaine.

24. The topical composition of claim 23, wherein the topical analgesic is lidocaine.

25. The topical composition of claim 24, wherein the lidocaine is present in an amount of about 4% by weight.

26. The topical composition of claim 21, wherein the absorbent is present in an amount of 0.1 wt% to 5 wt%.

27. The topical composition of claim 21, wherein the absorbent comprises a processed oat ingredient.

28. The topical composition of claim 27, wherein the processed oat ingredient comprises colloidal oatmeal.

29. The topical composition of claim 28, wherein the colloidal oatmeal is present in an amount of about 1% by weight.

30. The topical composition of claim 21, wherein the topical composition is substantially free of menthol and menthol lactate.

31. A method of relieving pain in a user with sensitive skin, the method comprising applying the topical composition of claim 21 to an external skin portion of the user's body in need of pain treatment.

32. A method of relieving pain in a user with sensitive skin, the method comprising topically applying a composition comprising lidocaine and colloidal oatmeal to an external skin portion of the user's body in need of pain treatment, wherein the composition is substantially free of volatile alcohols.

33. The method of claim 32, wherein the amount of lidocaine is 0.5 wt% to 8 wt%, and wherein the amount of colloidal oatmeal is 0.1 wt% to 5 wt%.

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