§333.310. Acne active ingredients.

21 C.F.R. § 333.310

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.

Notes, amendments, and revision history

[75 FR 9776, Mar. 4, 2010]

Source: 56 FR 41019, Aug. 16, 1991, unless otherwise noted.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Source: 52 FR 47322, Dec. 11, 1987, unless otherwise noted.

[75 FR 9776, Mar. 4, 2010]