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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 333 - Topical Antimicrobial Drug Products for over-the-Counter Human Use |
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Subpart D - Topical Acne Drug Products |
§ 333.310 - Acne active ingredients.
Latest version.
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§ 333.310 Acne active ingredients.
The active ingredient of the product consists of any of the following:
(a) Benzoyl peroxide, 2.5 to 10 percent.
(b) Resorcinol, 2 percent, when combined with sulfur in accordance with § 333.320(a).
(c) Resorcinol monoacetate, 3 percent, when combined with sulfur in accordance with § 333.320(b).
(d) Salicylic acid, 0.5 to 2 percent.
(e) Sulfur, 3 to 10 percent.
(f) Sulfur, 3 to 8 percent, when combined with resorcinol or resorcinol monoacetate in accordance with § 333.320.
[75 FR 9776, Mar. 4, 2010]