CFR - Code of Federal Regulations Title 21

The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR333.203]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 333 -- TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C - Topical Antifungal Drug Products

Sec. 333.203 Definitions.

As used in this subpart:

(a) Antifungal. A drug which inhibits the growth and reproduction of fungal cells and decreases the number of fungi present.

(b) Athlete's foot. An infection of the feet caused by certain dermatophytic fungi.

(c) Dermatophyte. A fungus that invades and lives upon the skin or in the hair or nails.

(d) Fungus. Any of a large division of plants, including dermatophytes, yeasts, and molds, characterized by a simple cell structure and the absence of chlorophyll.

(e) Jock itch. 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.

(f) Ringworm. A skin infection caused by certain dermatophytic fungi.