21 CFR 333.303 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 370-499) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 370-499) — Drugs For Human Use (Subpart A To Parts 370-499) — Topical Antimicrobial Drug Products For Over-The-Counter Human Use (Subpart A To § 333.350) — Topical Acne Drug Products (§ 333.301 To § 333.350) — 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.