Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-The-Counter Human Use; Final Rule
fda-drug · Food and Drug Administration · Rule · Published 2010-03-04 · Effective 2011-03-04 · 75 FR 9767
Document
Document number
2010-4424
Federal Register citation
75 FR 9767
CFR reference
21 CFR 333
Type
Rule
Action
Final rule.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2010-03-04
Effective date
2011-03-04
HHS docket
Docket Nos. FDA-1981-N-0114 and FDA-1992-N-0049
Abstract
We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products. In addition, this final rule includes new warnings and directions required for OTC acne drug products containing benzoyl peroxide. We are also revising labeling for OTC topical acne drug products containing resorcinol, resorcinol monoacetate, salicylic acid and/or sulfur to meet OTC drug labeling content and format requirements in a certain FDA regulation. This final rule is part of our ongoing review of OTC drug products and represents our conclusions on benzoyl peroxide in OTC acne drug products.