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

Resumen

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would amend the final 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 would add 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 proposal is part of the ongoing review of OTC drug products conducted by FDA.