FDA hand sanitizer registration, FDA requirements for hand sanitizer or   FDA  approval for hand sanitizer ; What is required?

FDA hand sanitizer registration, FDA requirements for hand sanitizer or   FDA  approval for hand sanitizer

FDA  approval for hand sanitizer – FDA approval is not required for OTC hand sanitizers. If you are planning to market  Alcohol or Benzalkonium based hand sanitizer, you have to comply with  FDA requirements for hand sanitizer listed below.

  1. Drug establishment registration
  2. US Agent appointment  (for foreign companies)
  3. Obtain a labeler code  
  4. Drug listing
  5. Compliance with FDA OTC drug labeling requirements
  6. The product should be manufactured according to Good Manufacturing  Practice. Please refer to 21  CFR 210 and 211.

FDA does not mention about GMP requirements for hand sanitizer formulated and manufactured according to FDA’s Temporary policy for hand sanitizers.


You can see more information about FDA’s temporary policy for hand sanitizer at the below link.

Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020

Hand sanitizer should be tested for the presence of potential impurities and residual solvents. 

More detailed information about control of impurities in hand sanitizer can be found at the below link.

How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer


FDAbasics can assist you in complying with FDA hand sanitizer registration and listing requirements for hand within the shortest possible time.


Drug establishment registration is required for the facility, which is engaged in the manufacturing /packing of the product.  Our fee drug establishment registration is $  299.


Labeler code is required for the private labler distributor and manufacturer of the product. Our fee for labeler code application assistance is $ 399.  Ten business days are required for the labeler code assignment.


Our fee for  NDC drug listing assistance is $ 399 per product listing; we offer a discount on multiple product listing.


We also assist companies in complying with FDA labeling requirements for hand sanitizers.  Our fee for labeling review assistance is $ 399 per product.

FDA may detain the hand sanitizer shipment, which does not comply with the above requirements.

If you have any questions related to FDA requirements for hand sanitizer or FDA hand sanitizer registration, please email your queries at [email protected], and we will immediately respond to all your questions.


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