FAQs
FAQ-OTC
We’ve organized our FAQs into categories below to help you find answers quickly. If you can’t find what you’re looking for, please don’t hesitate to contact us.
Yes,our factory had established a complete production system of OTC products (over-the-counter drugs) for American markets.We had got the cGMP production system and NSF certificates.We could provide the OTC products like Sunscreen,Anti-Ance,Anti-Antiperspirant,Anti-Drandruff and Anti-Bacterial products.
Pre-review of compliance for OTC Monographs
1) Formula review: Ensure that the combination and percentage of active ingredients complies with the FDA Monographs.
2) Label + Claim review:
3) Toxicological assessment of TRA
4) Active substance content test 5) USP51 Anti-corrosion challenge
6) USP 61+62 microbiological test
7) Human efficacy test
8) Other chemical tests: lead, cadmium, mercury, dioxane, Water Activity. 9) Allergy test
2. NDC code application +OTC listing registration
1)The FDA public information about the NDC enterprise registration, you can click on the link below: https://dps.fda.gov/decrs
2)The FDA public information about the OTC products registration, click on: https://dailymed.nlm.nih.gov/dailymed/ 3)The FDA public information about OTC Monographs,click on :https://dps.fda.gov/omuf/monographsearch