• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2017]
[CITE: 21CFR333.310]



TITLE 21--FOOD AND DRUGS
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

Sec. 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]

-
-