Comparatively Speaking: US FDA Categories of Hand Sanitizer Actives

Posted: September 23, 2009

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Triclosan, triclocarban, benzalkonium chloride, benzethonium chloride and parachlorometaxylenol, all potential active ingredients for skin disinfectants, are placed into Category III because the FDA has concluded that each lacked either safety or efficacy data sufficient for GRASE classification in hand sanitizers.

Since the monograph currently is in a tentative state, manufacturers are able to market hand sanitizers based on Category III ingredients. However, they are required by the FDA to submit further safety and/or efficacy data to prevent these ingredients from being excluded in the Final Monograph as GRASE active ingredients.

No natural product active ingredients, such as thyme, etc., currently are listed in the Monograph. Thus, natural antimicrobials are precluded from legal use in the United States, unless an approved New Drug Application (NDA) is obtained. At present, none have been granted.