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Antiseptic TFM "broad enough" to include antimicrobial lotions -- industry petition.

This article was originally published in The Tan Sheet

Executive Summary

ANTISEPTIC TFM "BROAD ENOUGH" TO INCLUDE ANTIMICROBIAL LOTIONS, NDMA and other industry groups maintain in a June 12 citizen petition to the agency. Submitted by the Nonprescription Drug Manufacturers Association in conjunction with the Cosmetic, Toiletry & Fragrance Association and the Soap & Detergent Association, the petition argues the scope of FDA's tentative final monograph for OTC health care antiseptic drug products includes lotions making antibacterial claims. "The section of the TFM addressing the antiseptic hand wash category is broad enough to encompass antimicrobial hand lotions, particularly in light of the fact that the TFM provides specific label directions for application of antiseptic hand washes without water or rinsing," the petition continues.
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