part_subject: "TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
subpart_code: "D"
subpart_subject: "Topical Acne Drug Products"
section_number: "333.303"
section_subject: "Definitions."
cfr_reference: "21 CFR 333.303"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
As used in this subpart:
(a)Acne. A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes.
(b)Acne blemish. A flaw in the skin resulting from acne.
(c)Acne drug product. A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads.
(d)Acne pimple. A small, prominent, inflamed elevation of the skin resulting from acne.
(e)Blackhead. A condition of the skin that occurs in acne and is characterized by a black tip.
(f)Whitehead. A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin.