OTC TOPICAL ANTIMICROBIAL TFM LISTS 14 INGREDIENTS AS CATEGORY I, 17 INGREDIENTS AS CATEGORY III; TRICLOCARBAN RECLASSIFIED AS CATEGORY III

Executive Summary

FDA's proposed list of Category I OTC antiseptic first aid ingredients includes 10 single agents and four combinations or complexes, according to an Antimicrobial Tentative Final Monograph (TFM) published in the July 22 Federal Register. The TFM proposes an additional 10 single ingredients and seven combinations and complexes for Category III status, requiring additional data to establish effectiveness. Mercury-containing antimicrobials and cloflucarban are Category II ingredients, those not generally recognized as safe and effective, according to the TFM (see chart below for list of FDA's proposed Category I and III ingredients). The July 22 document covers "first aid antiseptic drug products," defined as products which are "applied topically to the skin to help prevent infection in minor cuts, scrapes and burns" ("The Pink Sheet" July 22, T&G-1). The first aid TFM represents FDA's combination of three categories of related products which were considered separately by the OTC Antimicrobial Panel and in a previous Antimicrobial TFM published by FDA in 1978. The agency explained that two other classifications of antimicrobial ingredients -- antimicrobial soaps and antimicrobial cleansing preparations intended for professional use -- will be addressed in future TFMs. One proposed Category III ingredient, triclocarban, was previously classified Category II in the 1978 TFM. However, FDA said it "has reassessed data that were discussed in the [OTC Review] Panel's report . . . in light of the first aid antiseptic category, and is proposing a Category III classification. . . ." Chart omitted.