You ask…. Why do you call your patches “topical” rather than “transdermal”?
We answer… A transdermal patch contains a drug. A drug is something that has gone through the process of approval by the FDA. This includes millions of dollars in testing, trials, and approvals. Check out the FDA’s slideshow explaining what an OTC drug is here.
At American Custom Technologies, we’ve been in the business of patch manufacturing for over 20 years.
We’re familiar with the various FDA regulations around labeling and claims, and we’re careful with our nomenclature.
No one wants the FDA to recall their product because of one wrong word!
Most of our customers are not in the OTC drug market. They make vitamin patches, nutraceuticals, and cosmetic patches. They don’t make claims – because they don’t want to create a drug. This means our customers don’t have to spend the tens of thousands of dollars on clinical trials to prove that their products pass through the dermis. If our customers do want that testing, for their own knowledge, we can arrange that through a third-party lab.
Because we’re careful, we use the word “topical” to describe our patches.
We use the same quality patch materials and manufacturing procedures when we produce a vitamin patch as when we manufacture a lidocaine or menthol patch. Our films and foams create an occlusive barrier. We not only have been in the business for over twenty years, we consult with an expert who instructs on transdermal delivery and refuse to manufacture product that we know will be unfit for use in a patch.
Our quality remains the same, no matter what we make.