Topical Antiseptic Drug Products

The completion of the monograph for over-the-counter (OTC) Consumer and Health Care Antiseptic Products is part of FDA’s larger, ongoing review of antiseptic active ingredients to determine whether these active ingredients are safe and effective for use in antiseptic drug products.

FDA Public Communications

• FDA issues final rule on safety and effectiveness of consumer hand sanitizers, 2019 
• If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative, 2019 
• FDA issues final rule on safety and effectiveness for certain active ingredients in over-the-counter health care antiseptic hand washes and rubs in the medical setting, 2017
• FDA issues final rule on safety and effectiveness of antibacterial soaps, 2016
• FDA requests additional information to address data gaps for certain active ingredient in consumer hand sanitizers, 2016
• FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics, 2015
• FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection

FDA Letters

• Antiseptic Deferral Letters

Meetings

• Meetings with industry on consumer and health care antiseptics

Additional Background Information

• September 3, 2014, Non-Prescription Drug Advisory Committee Meeting
• Rulemaking History for OTC Topical Antimicrobial Drug Products
• Past public meetings relevant to consumer and health care antiseptics
• Consumer Information on Consumer and Health Care Antiseptics