Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC First Aid Antibiotic Drug Products

The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) first aid antibiotic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). The amendment adds a warning statement concerning allergic reactions resulting from topical antibiotic drug products containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, or polymyxin B sulfate. This final rule is part of the ongoing review of OTC drug products conducted by FDA.