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Hand sanitizer

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 sanitizer's are ethyl alcohol or ethanol complying with OTC Monograph not final part 333 A.

Commonly used non-alcohol active ingredients in Hand sanitizers are benzalkonium chloride and triclosan which are also in OTC Monograph not final part 333A.

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.

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