Food and Drug Administration, HHS § 333.250

(b) Athlete’s foot. An infection of the of this chapter, subject to the provi- feet caused by certain dermatophytic sions of section 502 of the Federal fungi. Food, Drug, and Cosmetic Act (the act) (c) Dermatophyte. A fungus that in- relating to misbranding and the prohi- vades and lives upon the skin or in the bition in section 301(d) of the act hair or nails. against the introduction or delivery for (d) Fungus. Any of a large division of introduction into interstate commerce plants, including dermatophytes, of unapproved new drugs in violation of yeasts, and molds, characterized by a section 505(a) of the act. simple cell structure and the absence (1) For products containing any ingre- of chlorophyll. dient identified in § 333.210 labeled for the (e) Jock itch. A chronic and recurrent treatment of athlete’s foot, jock itch, and infection caused by certain ringworm. (i) (Select one of the fol- dermatophytic fungi; affects the upper, lowing: ‘‘Treats,’’ ‘‘For the treatment inner thighs and sometimes extends to of,’’ ‘‘For effective treatment of,’’ the groin and the pubic area; the condi- ‘‘Cures,’’ ‘‘For the cure of,’’ ‘‘Clears tion most frequently occurs in men, up,’’ or ‘‘Proven clinically effective in but may also occur in women. the treatment of’’) ‘‘most’’ (select one (f) Ringworm. A skin infection caused condition from any one or more of the by certain dermatophytic fungi. following groups of conditions: § 333.210 Antifungal active ingredi- (A) ‘‘Athlete’s foot,’’ athlete’s foot ents. (dermatophytosis),’’ ‘‘athlete’s foot (tinea pedis),’’ or ‘‘tinea pedis (ath- The active ingredient of the product lete’s foot)’’; consists of any one of the following within the specified concentration es- (B) ‘‘Jock itch,’’ ‘‘jock itch (tinea tablished for each ingredient: cruris),’’ or ‘‘tinea cruris (jock itch)’’; (a) Clioquinol 3 percent. or (b) Haloprogin 1 percent. (C) ‘‘Ringworm,’’ ‘‘ringworm (tinea (c) Miconazole nitrate 2 percent. corporis),’’ or ‘‘tinea corporis (d) Povidone-iodine 10 percent. (ringworm).’’) (e) Tolnaftate 1 percent. (ii) In addition to the information (f) Undecylenic acid, calcium identified in paragraph (b)(1)(i) of this undecylenate, copper undecylenate, section, the labeling of the product and zinc undecylenate may be used in- may contain the following statement: dividually or in any ratio that provides (Select one of the following: ‘‘Re- a total undecylenate concentration of lieves,’’ ‘‘For relief of,’’ ‘‘For effective 10 to 25 percent. relief of,’’ or ‘‘Soothes,’’) (select one or (g) Clotrimazole 1 percent. more of the following: ‘‘Itching,’’ [58 FR 49898, Sept. 23, 1993, as amended at 67 ‘‘scaling,’’ ‘‘cracking,’’ ‘‘burning,’’ FR 5943, Feb. 8, 2002] ‘‘redness,’’ ‘‘soreness,’’ ‘‘irritation,’’ ‘‘discomfort,’’ ‘‘chafing associated with § 333.250 Labeling of antifungal drug jock itch,’’ ‘‘itchy, scaly skin between products. the toes,’’ or ‘‘itching, burning feet’’). (a) Statement of identity. The labeling (2) For products containing the ingre- of the product contains the established dient identified in § 333.210(e) labeled for name of the drug, if any, and identifies the prevention of athlete’s foot. (i) (Se- the product as an ‘‘antifungal.’’ lect one of the following: ‘‘Clinically (b) Indications. The labeling of the proven to prevent,’’ ‘‘Prevents,’’ product states, under the heading ‘‘In- ‘‘Proven effective in the prevention dications,’’ the phrase listed in para- of,’’ ‘‘Helps prevent,’’ ‘‘For the preven- graph (b)(1)(i) of this section and may tion of,’’ ‘‘For the prophylaxis (preven- contain the additional phrase listed in tion) of,’’ ‘‘Guards against,’’ or ‘‘Pre- paragraph (b)(1)(ii) of this section. vents the recurrence of’’) ‘‘most’’ (se- Other truthful and nonmisleading lect one of the following: ‘‘Athlete’s statements, describing only the indica- foot,’’ ‘‘athlete’s foot tions for use that have been established (dermatophytosis),’’ ‘‘athlete’s foot in paragraph (b) of this section, may (tinea pedis),’’ or ‘‘tinea pedis (ath- also be used, as provided in § 330.1(c)(2) lete’s foot)’’) ‘‘with daily use.’’

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