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Benzalkonium Chloride Antimicrobial Handwash Kills 98% Of Staph - ILTC

This article was originally published in The Tan Sheet

Executive Summary

Inclusion of benzalkonium chloride as a Category I ingredient in the tentative final monograph for OTC topical antimicrobial drug products is requested by International Laboratory Technology Corp. in a citizen petition submitted to FDA April 6.

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Benzalkonium chloride

FDA should not clear the ingredient for chronic use in health care antiseptic drug products due to a lack of data demonstrating long-term safety, Lonza's counsel says in an Aug. 3 letter. Responding to a citizen petition filed by International Laboratory Technology Corp. requesting GRAS/E status for the ingredient in OTC topical antimicrobial products, Lonza notes the agency has required data on chronic toxicity for a number of ingredients evaluated in the health care antiseptic drug products monograph, but the studies submitted by ILTC do not address long-term use. FDA currently considers benzalkonium chloride (.11%-.13%) a Category III ingredient - data insufficient to demonstrate safety/efficacy - except for short-term use (1"The Tan Sheet" April 24, p. 9)

Benzalkonium chloride

FDA should not clear the ingredient for chronic use in health care antiseptic drug products due to a lack of data demonstrating long-term safety, Lonza's counsel says in an Aug. 3 letter. Responding to a citizen petition filed by International Laboratory Technology Corp. requesting GRAS/E status for the ingredient in OTC topical antimicrobial products, Lonza notes the agency has required data on chronic toxicity for a number of ingredients evaluated in the health care antiseptic drug products monograph, but the studies submitted by ILTC do not address long-term use. FDA currently considers benzalkonium chloride (.11%-.13%) a Category III ingredient - data insufficient to demonstrate safety/efficacy - except for short-term use (1"The Tan Sheet" April 24, p. 9)

Topical Antimicrobial Test Standards Created By Third Party Possible - FDA

FDA is willing to consider working with third-party standard-setting organizations to develop testing methodologies for the healthcare antiseptic products final monograph.

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