FDA Breaks Out Topical Acne OTC Guidance

摘要

In a small entity compliance guide, FDA outlines new warnings and directions for OTC topical acne products containing benzoyl peroxide. The agency added the active ingredient to the acne monograph in March 2010, nearly 19 years after it added the four other active ingredients to the monograph in a final rule ("FDA Tempers Benzoyl Peroxide's GRASE Status With Additional Warnings,"