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GUIDANCE DOCUMENT

Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry Guidance for Industry December 2020

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2016-N-0124
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR) (84 FR 14847, April 12, 2019), which applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products that are sometimes referred to as rubs, leave-on products, or hand sanitizers. The Consumer Antiseptic Rub FR also applies to active ingredients used in OTC consumer antiseptic wipes.

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All written comments should be identified with this document's docket number: FDA-2016-N-0124 .

 
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