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OTC First Aid Antibiotic monograph

Executive Summary

Based on petitions submitted by Burroughs Wellcome, Sterling and Upjohn, FDA is proposing to amend the final OTC rulemaking to allow certain bacitracin zinc/neomycin sulfate/polymyxin B sulfate ointment/cream combinations with Category I amine or "caine" -type local anesthetics. The proposed amendment is published in the June 8 Federal Register.

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