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FDA Denies Citizen Petition To Amend OTC Topical Drugs Monograph

This article was originally published in The Tan Sheet

Executive Summary

FDA cites insufficient evidence in rejecting a citizen petition filed by a New Jersey podiatrist to amend the proposed monograph for topical OTC First Aid Antibiotic Drug Products

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Inclusion of bacitracin/polymyxin/vitamin E/mixed oils ointment in OTC monograph requested by New Jersey podiatrist in citizen petition to FDA. Petition asks agency to lower required dosages of bacitracin, polymyxin and allow distribution of combo containing polymyxin B-sulfate (892 units/g of finished product), bacitracin zinc (44.05 units/g), vitamin E (141 IU/g) and blend of paraffin, fragrance, mineral oil, cod liver oil, lanolin and petrolatum...

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