Hand sanitizer Registration with FDA

Antiseptic Hand sanitizers are OTC drugs which require FDA establishment registration, Drug listing and NDC Labeler code also known as NDC Number. The most common active ingredient used in Hand sanitizers are ethyl alcohol or ethanol and Isopropyl alcohol complying with OTC Monograph not final part 333 A.

Commonly used non-alcohol active ingredient in Hand sanitizers is benzalkonium chloride which is also in OTC Monograph not final part 333A. FDA’s final rule made triclosan (another popular ingredient) as ineligible for the purpose of hand sanitizer.

FDA issued a guidance on March 2020 with temporary policy for manufacturing of hand sanitizer products during covid-19 pandemic. In this guidance FDA provide the formulation and labeling for hand sanitizer manufacturer. Even though the manufacturer follows the guidance, they need to comply with FDA Registration, NDC labeler code and hand sanitizer listing requirements.

FDA Registration Renewal – Hand Sanitizer

All hand sanitizer manufacturers registered before October 1 must renew the registration before December 31 to keep the registration active for next year. The hand sanitizer listing completed in current year is valid December 31st of next year.

If you are looking for assistance in preparing and submitting SPL files for antiseptic drug products, LMG can help you in SPL preparation and submission to FDA.

FDA issued final guidance on Antiseptic hand sanitizer, please visit FDA antiseptic hand sanitizer final rule

Hand sanitizer FDA establishment registration form

Hand sanitizer FDA listing form

Hand Sanitizer GMP

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Hand sanitizer FDA Registration

Hand sanitizer FDA labeling

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