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21 CFR § 333.303 - Definitions.

---
identifier: "/us/cfr/t21/s333.303"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 333.303 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "333.303"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "333"
part_name: "TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "52 FR 47322, Dec. 11, 1987, unless otherwise noted."
cfr_part: "333"
---

# 333.303 Definitions.

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.