Title 21 CFR reference

(a) An over-the-counter skin protectant drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient: (a) Allantoin, 0.5 to 2 percent. (b) Aluminum hydroxide gel, 0.15 to 5 percent. (c) Calamine, 1 to 25 percent. (d) Cocoa butter, 50 to 100 percent. (e) Cod liver oil, 5 to 13.56 percent, in accordance with § 347.20(a)(1) or (a)(2), provided the product is labeled so that the quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400 U.S.P. Units cholecalciferol. (f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4). (g) Dimethicone, 1 to 30 percent. (h) Glycerin, 20 to 45 percent. (i) Hard fat, 50 to 100 percent. (j) Kaolin, 4 to 20 percent. (k) Lanolin, 12.5 to 50 percent. (l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4). (m) Petrolatum, 30 to 100 percent. (n) [Reserved] (o) Sodium bicarbonate. (p) [Reserved] (q) Topical starch, 10 to 98 percent. (r) White petrolatum, 30 to 100 percent. (s) Zinc acetate, 0.1 to 2 percent. (t) Zinc carbonate, 0.2 to 2…

The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient: (a) Aluminum acetate, 0.13 to 0.5 percent (depending on the formulation and concentration of the marketed product, the manufacturer must provide adequate directions so that the resulting solution to be used by the consumer contains 0.13 to 0.5 percent aluminum acetate). (b) Aluminum sulfate, 46 to 63 percent (the concentration is based on the anhydrous equivalent). (c) Witch hazel.

Combinations of skin protectant active ingredients.(a) (1) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to § 347.50(b)(1) and provided each ingredient in the combination is within the concentration specified in § 347.10. (2) Any two or more of the ingredients identified in § 347.10(a), (d), (e), (g), (h), (i), (k), (l), (m), and (r) may be combined provided the combination is labeled according to § 347.50(b)(2) and provided each ingredient in the combination is within the concentration specified in § 347.10. (3) Any two or more of the ingredients identified in § 347.10(b), (c), (j), (s), (t), and (u) may be combined provided the combination is labeled according to § 347.50(b)(3) and provided each ingredient in the combination is within the concentration specified in § 347.10. (4) The ingredients identified in § 347.10(f) and (l) may be combined provided the combination is labeled according to § 347.50(b)(7) and provided each ingredient in the combination is within the concentration specified in § 347.10. Combination of ingredients to prepare an aluminum acetate…

As used in this part: Astringent drug product. A drug product applied to the skin or mucous membranes for a local and limited protein coagulant effect. Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called “lip balm.” Poison ivy, oak, sumac dermatitis. An allergic contact dermatitis due to exposure to plants of the genus Rhus (poison ivy, poison oak, poison sumac), which contain urushiol, a potent skin-sensitizer. Skin protectant drug product. A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces. [68 FR 33376, June 4, 2003]

A skin protectant drug product may have more than one labeled use and labeling appropriate to different uses may be combined to eliminate duplicative words or phrases as long as the labeling is clear and understandable. When the labeling of the product contains more than one labeled use, the appropriate statement(s) of identity, indications, warnings, and directions must be stated in the labeling. Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product with one or more of the following: For any product.(1) “Skin protectant” (optional, may add dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”). For any product formulated as a lip protectant.(2) “Skin protectant,” “lip protectant,” or “lip balm” (optional, may add dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”). For products containing any ingredient in § 347.10(b), (c), (j), (s), (t), and (u).(3) “Poison ivy, oak, sumac drying” (optional, may add dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”). For products containing any ingredient in § 347.10(b), (c), (f), (j), (o), (s), (t), and (u).(4) “Poison ivy, oak, sumac…

Statement of identity.For products containing the combination of aluminum sulfate tetradecahydrate and calcium acetate monohydrate identified in § 347.20(b)(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent.” , under the “Purpose” heading identified in § 201.66(c)(3) of this chapter, the labeling of each active ingredient in the product states “Astringent*”, which is followed by the statements “* When combined together in water, these ingredients form the active ingredient aluminum acetate. See [the following in bold italic type] Directions.” Indications.(b) The labeling of the product states, under the heading “Uses” any of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition of section 301(d) of the act against the introduction or delivery for introduction…

The statement of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Statement of identity.(a) For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of the applicable OTC drug monographs. Indications.(b) The labeling of the product states, under the heading “Uses,” the indication(s) for each ingredient in the combination as established in the indications sections of the applicable OTC drug monographs, unless otherwise stated in this paragraph (b). Other truthful and nonmisleading statements, describing only the…