Topical Acne Drug Products for Over-the-Counter Human Use–Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry

Issue Date: June 21, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling, Over-the-Counter Drugs
Status: Final

Topical Acne Drug Products for Over-the-Counter Human Use–Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry

This guidance is intended to help small businesses understand and comply with FDA’s regulation regarding over-the-counter (OTC) topical acne drug products published in the Federal Register on March 4, 2010 (75 FR 9767). The final rule makes the following changes to the OTC regulations at 21 CFR 333, subpart D: FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).

Download the Guidance Document