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# Small Business Consumer Antiseptic Wash Guidance
- URL: https://www.fdaweb.com/small-business-consumer-antiseptic-wash-guidance/
- Published: 2017-07-25T12:00:00.000Z
- Updated: 2026-09-14T22:36:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139216

FDA has issued a guidance, *Consumer Antiseptic Wash Final Rule*, to help small businesses better understand and comply with a final rule establishing that certain active ingredients used in over-the-counter consumer antiseptic wash products are not generally recognized as safe and effective (GRASE) and thus are not eligible for inclusion in the OTC topical antiseptic monograph. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM568513.pdf?ref=fdaweb.com) says that on 9/6/16, FDA published a final rule that finalizes the non-monograph status of 19 active ingredients, including triclosan and triclocarban, which are intended for use in OTC consumer antiseptic wash products.

A decision was deferred on three active ingredients — benzalkonium, benzethonium chloride, and chloroxylenol — to allow more time for sponsors who proposed to complete the studies necessary to fill the safety and effectiveness data gaps identified for those ingredients, FDA says.

Consumer antiseptic wash products containing one or more of the non-GRASE ingredients will be considered new drugs for which approved NDAs are required for marketing, the guidance says. The final rule is effective 9/6.