Antifungal Products

A product with the intended use to treat or prevent fungus (an "antifungal") is a drug. Antifungal products include those intended to treat athlete's foot, jock itch and ringworm (all forms of fungi).

If you make any claims that make the consumer think that the intended use of the product is to treat or prevent fungal infections, then the product is a drug.

OTC Antifungal Products

There are non-prescription antifungal products on the market that often look like cosmetics but are, in fact, over-the-counter drugs. In order to be marketed to treat fungal infections they must meet the OTC Monograph for topical antifungal drug products, using only approved ingredients, label claims, directions, and warning statements.

Reality vs Regulation

There are natural substances, including several essential oils, that are known as antifungals and which may be effective in treating fungal infections. However, none of these are in the list of approved ingredients for OTC antifungal products.

Rightly or wrongly, only products which meet the OTC monograph for antifungal treatment may be promoted and sold as antifungal products.

Also keep in mind that even if you could get the ingredients and make a product that meets the requirements, in order for the product to be legally marketed it must be manufactured in a facility that is registered as a drug manufacturer with the FDA and in which follow drug good manufacturing practices as contained in federal regulations are followed. It is likely there are state-level drug manufacturing registration and licensing requirements.