From monograph-compliant actives to finished, labeled product, we formulate and manufacture OTC drugs and topical products across skincare, intimate wellness, bath & body, aftercare, and wipes, in an FDA-registered, cGMP facility.
SOURCE: Research and Markets, OTC Topical Drugs Market Report 2026
OTC products aren’t cosmetics. They’re regulated drugs. That means monograph review, active ingredient documentation, and a facility that’s actually registered to produce them.
We built our process around that from day one.
Active and renewed annually, on file for every client.
Every batch produced to 21 CFR Part 211-aligned practice.
We confirm which FDA monograph applies before formulation starts.
Benzalkonium chloride, lidocaine, benzocaine, and more.
Challenge testing available for every formula on request.
Claims and label copy reviewed against monograph rules.
Start from a proven, monograph-compliant base and launch faster.
Curious about the service? Get in touch with us and we’ll send you your very own sample kit. Get a first hand view of what it will be like working with us and let us show you everything we have in store to help boost your brand!
