Hand Sanitizer Registration
FDA Approval for Hand Sanitizers is needed to market products in the United States.Any products containing Ethyl Alcohol or Benzalkonium need to be registered and must comply with FDA requirements for Hand Sanitizer.
The following is needed for Hand Sanitizer Registration
Drug Establishment Registration
U.S Agent Appointee
Good Manufacturing Practices (GMP)
FDA Registration Assistance can help you obtain FDA approval for your Hand Sanitizer products. We help you obtain this in less that 15 business days. Below are the costs and timelines for every part of the Hand Sanitizer Registration process.
Drug Establishment Registration : $449 USD per year ( takes approximately 2 business days) (includes U.S Agent Fee)
DUNS Number : $99 USD (takes approximately 2 -3 business days)
Labeler Code : $349 USD (takes approximately 10 business days)
Drug Listing / NDC : $199 USD each product listing (takes 1 business days)
Total Cost for the 1st Hand Sanitizer product is $1,099 USD including DUNS number registration.
If you are interested in getting your Hand Sanitizer Products registered please feel to reach out to us via email at firstname.lastname@example.org