Title 21 CFR reference

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

As used in this subpart: First aid antibiotic. An antibiotic-containing drug product applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns. [52 FR 47322, Dec. 11, 1987, as amended at 64 FR 403, Jan. 5, 1999]

The product consists of any of the following active ingredients within the specified concentration established for each ingredient and in the specified dosage form: (a) Bacitracin ointment containing, in each gram, 500 units of bacitracin in a suitable ointment base. (b) Bacitracin zinc ointment containing, in each gram, 500 units of bacitracin zinc in a suitable ointment base. (c) Chlortetracycline hydrochloride ointment containing, in each gram, 30 milligrams of chlortetracycline hydrochloride in a suitable ointment base. (d) Neomycin sulfate ointment containing, in each gram, 3.5 milligrams of neomycin in a suitable water soluble or oleaginous ointment base. (e) Neomycin sulfate cream containing, in each gram, 3.5 milligrams of neomycin in a suitable cream base. (f) Tetracycline hydrochloride ointment containing, in each gram, 30 milligrams of tetracycline hydrochloride in a suitable ointment base. [52 FR 47322, Dec. 11, 1987, as amended at 53 FR 18838, May 25, 1988; 64 FR 403, Jan. 5, 1999]

The following combinations are permitted provided each active ingredient is present within the established concentration and in the specified dosage form, and the product is labeled in accordance with § 333.160. Combinations of antibiotic active ingredients.(a) (1) Bacitracin-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base. (2) Bacitracin-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram, in a suitable ointment base the following: (i) 500 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; or (ii) 400 units of bacitracin, 3.5 milligrams of neomycin, and 5,000 units of polymyxin B; (3) Bacitracin-polymyxin B sulfate topical aerosol containing, in each gram, 500 units of bacitracin and 5,000 units of polymyxin B in a suitable vehicle, packaged in a pressurized container with suitable inert gases. (4) Bacitracin zinc-neomycin sulfate ointment containing, in each gram, 500 units of bacitracin and 3.5 milligrams of neomycin in a suitable ointment base. (5) Bacitracin zinc-neomycin sulfate-polymyxin B sulfate ointment containing, in each gram,…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “first aid antibiotic.” Indications.(b) The labeling of the product states, under the heading “Indications,” the following: “First aid to help” [select one of the following: “prevent,” (“decrease” (“the risk of” or “the chance of”)), (“reduce” (“the risk of” or “the chance of”)), “guard against,” or “protect against”] [select one of the following: “infection,” “bacterial contamination,” or “skin infection”] “in minor cuts, scrapes, and burns.” 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), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) “For external use only. Do not use in…

Statements 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 “Indications,” 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. Other truthful and nonmisleading statements, describing only the…

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

As used in this subpart: Antifungal.(a) A drug which inhibits the growth and reproduction of fungal cells and decreases the number of fungi present. Athlete's foot.(b) An infection of the feet caused by certain dermatophytic fungi. Dermatophyte.(c) A fungus that invades and lives upon the skin or in the hair or nails. Fungus.(d) Any of a large division of plants, including dermatophytes, yeasts, and molds, characterized by a simple cell structure and the absence of chlorophyll. Jock itch.(e) A chronic and recurrent infection caused by certain dermatophytic fungi; affects the upper, inner thighs and sometimes extends to the groin and the pubic area; the condition most frequently occurs in men, but may also occur in women. Ringworm.(f) A skin infection caused by certain dermatophytic fungi.

The active ingredient of the product consists of any one of the following within the specified concentration established for each ingredient: (a) Clioquinol 3 percent. (b) Haloprogin 1 percent. (c) Miconazole nitrate 2 percent. (d) Povidone-iodine 10 percent. (e) Tolnaftate 1 percent. (f) Undecylenic acid, calcium undecylenate, copper undecylenate, and zinc undecylenate may be used individually or in any ratio that provides a total undecylenate concentration of 10 to 25 percent. (g) Clotrimazole 1 percent. [58 FR 49898, Sept. 23, 1993, as amended at 67 FR 5943, Feb. 8, 2002]

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antifungal.” Indications.(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1)(i) of this section and may contain the additional phrase listed in paragraph (b)(1)(ii) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established in paragraph (b) of this section, 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 in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. For products containing any ingredient identified in § 333.210 labeled for the treatment of athlete's foot, jock itch, and ringworm.(1) (i) (Select one of the following: “Treats,” “For the treatment of,” “For effective treatment of,” “Cures,” “For the cure of,” “Clears up,” or “Proven…

The labeling provided to health professionals (but not to the general public) may contain the following additional indication: For products containing haloprogin or miconazole nitrate identified in § 333.210 (a) and (c).Candida albicans(a) “For the treatment of superficial skin infections caused by yeast ().” (b) [Reserved]

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

As used in this subpart: Acne.(a) A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes. Acne blemish.(b) A flaw in the skin resulting from acne. Acne drug product.(c) A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads. Acne pimple.(d) A small, prominent, inflamed elevation of the skin resulting from acne. Blackhead.(e) A condition of the skin that occurs in acne and is characterized by a black tip. Whitehead.(f) A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin.

The active ingredient of the product consists of any of the following: (a) Benzoyl peroxide, 2.5 to 10 percent. (b) Resorcinol, 2 percent, when combined with sulfur in accordance with § 333.320(a). (c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with § 333.320(b). (d) Salicylic acid, 0.5 to 2 percent. (e) Sulfur, 3 to 10 percent. (f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with § 333.320. [75 FR 9776, Mar. 4, 2010]

(a) Resorcinol identified in § 333.310(b) may be combined with sulfur identified in § 333.310(f). (b) Resorcinol monoacetate identified in § 333.310(c) may be combined with sulfur identified in § 333.310(f). [75 FR 9776, Mar. 4, 2010]

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “acne medication,” “acne treatment,” “acne medication” (insert dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”), or “acne treatment” (insert dosage form, e.g., “cream,” “gel,” “lotion,” or “ointment”). Indications.(b) The labeling of the product states, under the heading “Indications,” the phrase listed in paragraph (b)(1) of this section and may contain any of the additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, 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 in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) “For the” (select one of the following: “management” or “treatment”) “of…