232 Subpart C—Topical Antifungal Drug Products

§ 333.201 21 CFR Ch. I (4–1–11 Edition)

When the time intervals or age limita- within the specified concentration es- tions for administrations of the indi- tablished for each ingredient: vidual ingredients differ, the directions (a) Clioquinol 3 percent. for the combination product may not (b) Haloprogin 1 percent. exceed any maximum dosage limits es- (c) Miconazole nitrate 2 percent. tablished for the individual ingredients (d) Povidone-iodine 10 percent. in the applicable OTC drug monograph. (e) Tolnaftate 1 percent. (f) Undecylenic acid, calcium Subpart C—Topical Antifungal undecylenate, copper undecylenate, Drug Products and zinc undecylenate may be used in- dividually or in any ratio that provides SOURCE: 58 FR 49898, Sept. 23, 1993, unless a total undecylenate concentration of otherwise noted. 10 to 25 percent. (g) Clotrimazole 1 percent. § 333.201 Scope. [58 FR 49898, Sept. 23, 1993, as amended at 67 (a) An over-the-counter antifungal FR 5943, Feb. 8, 2002] drug product in a form suitable for topical administration is generally recog- § 333.250 Labeling of antifungal drug nized as safe and effective and is not products. misbranded if it meets each of the con- (a) Statement of identity. The labeling ditions in this subpart and each gen- eral condition established in § 330.1 of of the product contains the established this chapter. name of the drug, if any, and identifies (b) Reference in this subpart to regu- the product as an ‘‘antifungal.’’ latory sections of the Code of Federal (b) Indications. The labeling of the Regulations are to chapter I of title 21 product states, under the heading ‘‘In- unless otherwise noted. dications,’’ the phrase listed in paragraph (b)(1)(i) of this section and may § 333.203 Definitions. contain the additional phrase listed in As used in this subpart: paragraph (b)(1)(ii) of this section. (a) Antifungal. A drug which inhibits Other truthful and nonmisleading the growth and reproduction of fungal statements, describing only the indica- cells and decreases the number of fungi tions for use that have been established present. in paragraph (b) of this section, may (b) Athlete’s foot. An infection of the also be used, as provided in § 330.1(c)(2) feet caused by certain dermatophytic of this chapter, subject to the provi- fungi. sions of section 502 of the Federal (c) Dermatophyte. A fungus that in- Food, Drug, and Cosmetic Act (the act) vades and lives upon the skin or in the relating to misbranding and the prohi- hair or nails. bition in section 301(d) of the act (d) Fungus. Any of a large division of against the introduction or delivery for plants, including dermatophytes, introduction into interstate commerce yeasts, and molds, characterized by a of unapproved new drugs in violation of simple cell structure and the absence section 505(a) of the act. of chlorophyll. (1) For products containing any ingre- (e) Jock itch. A chronic and recurrent dient identified in § 333.210 labeled for the infection caused by certain treatment of athlete’s foot, jock itch, and dermatophytic fungi; affects the upper, ringworm. (i) (Select one of the fol- inner thighs and sometimes extends to lowing: ‘‘Treats,’’ ‘‘For the treatment the groin and the pubic area; the condi- of,’’ ‘‘For effective treatment of,’’ tion most frequently occurs in men, ‘‘Cures,’’ ‘‘For the cure of,’’ ‘‘Clears but may also occur in women. up,’’ or ‘‘Proven clinically effective in (f) Ringworm. A skin infection caused the treatment of’’) ‘‘most’’ (select one by certain dermatophytic fungi. condition from any one or more of the following groups of conditions: § 333.210 Antifungal active ingredi- (A) ‘‘Athlete’s foot,’’ athlete’s foot ents. (dermatophytosis),’’ ‘‘athlete’s foot The active ingredient of the product (tinea pedis),’’ or ‘‘tinea pedis (ath- consists of any one of the following lete’s foot)’’;

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