If there is a “drug facts” label on the package or insert and the ingredient list separates and calls out an “active ingredient,” it is an OTC drug. An ingredient cannot be listed as an “active ingredient” on a purely cosmetic product.
- Active Ingredient: Used only in FDA-regulated OTC drug products
- Purpose: The intended action(s) of the OTC drug product
- Uses: The specific indication(s) or approved use(s) for the OTC drug product
- Warnings: Any known possible contraindications or adverse effects of the product; this information is required on all drugs but not on cosmetics.
- Directions: Recommended manner set forth by the applicable drug monograph.
- Inactive ingredients: Other ingredients in the product that are not regulated as OTC drugs; these ingredients may provide other cosmetic benefits not indicated under “uses.”