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52 FR 47322, Dec. 11, 1987, unless otherwise noted.
56 FR 41019, Aug. 16, 1991, unless otherwise noted.
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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.