do topical sanitizers have to be approved bythe fda

Hand Sanitizer Regulations - FDA Regulations for Hand ...- do topical sanitizers have to be approved bythe fda ,3. Hand sanitizer listing with FDA – Assign a unique 10-digit NDC number and List each hand sanitizer with FDA. 4. Label Compliance – Antiseptic hand sanitizer must have "Drug Facts" labeling and all other required information's. 5. Comply with GMP Requirements as per 21 CFR 211 - Hand Sanitizer GMP. 6.FDA requirements for hand sanitizers - Summary FDA ...Summary of FDA requirements for Hand Sanitizers. To market over-the-counter drug (OTC monograph) products such as hand sanitizers, you should comply with the requirements listed below. Make sure the active ingredients and indication are complying with the OTC monograph. Drug establishment registration. Obtaining the labeler code. NDC Drug listing.