C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart D—Topical Acne Drug Products

21 C.F.R. § 333.310

Acne active ingredients

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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]
Notes of Decisions
Cited in 2 cases (2 in the last 5 years), 2024–2026 · leading case: Williams v. Galderma Labs., LP (N.D. Ill. 2024).
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Williams v. Galderma Labs., LP (N.D. Ill. 2024). “, Over-the- Counter (OTC) Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use3; see also 21 C.F.R. § 333.310 (a); 21 C.F.R. § 333.”
In re Target Corp. BPO Sales & Mktg. Litig. (D. Minnesota 2026). “21 C.F.R. § 333.310(a); see Howard v. Alchemee, LLC, No.”
— 21 C.F.R. § 333.310(a) — 1 case
In re Target Corp. BPO Sales & Mktg. Litig. (D. Minnesota 2026). “21 C.F.R. § 333.310(a); see Howard v. Alchemee, LLC, No.”
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