How to get FDA approval for Hand Sanitizers

FDA does not approve OTC hand sanitizers, you can sell hand sanitizers by complying with “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry” .   You can find an overview of the FDA’s temporary policy on our website.  FDAbasics can assist you to comply with the below requirements.

  1. Drug establishment  registration
  2. Obtaining the labeler code
  3. Labeling compliance
  4. NDC  Drug  Listing.





Disclaimer   – This article reflects current understanding of FDAbasics LLC ,  does not constitute legal bindings. FDAbasics LLC is a private regulatory   not associated with US FDA. 


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