FDA Registration for Wart Remover Drug Products
Wart remover products containing salicylic acid (up to 40%) are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.
FDA Requirements for Wart Remover Drug Products
Wart remover drug products are regulated by FDA. Salicylic acid (up to 40%) is the active ingredient permitted under the OTC Wart Remover Monograph for common warts and plantar warts.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
The U.S. Food and Drug Administration (FDA) regulates certain over-the-counter (OTC) wart remover products through a monograph system. This monograph outlines the specific ingredients, concentrations, and forms that qualify an OTC wart remover as safe and effective. The only approved ingredient for these OTC products is salicylic acid, at concentrations between 5% and 40% depending on the delivery method (plaster, collodion, or karaya gum base). These products are intended for the removal of common and plantar warts.
Wart Remover – Active Ingredients and OTC Monograph Number
| Active Ingredients | OTC Monograph Number |
|---|---|
| Salicylic acid 12 to 40 percent in a plaster vehicle | M028.10 (Part 358) |
| Salicylic acid 5 to 17 percent in a collodion-like vehicle | M028.10 (Part 358) |
| Salicylic acid 15 percent in a karaya gum, glycol plaster vehicle | M028.10 (Part 358) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
Wart Remover Drug Products — FAQs
Are wart remover products regulated as drugs?
What concentration of salicylic acid is allowed in OTC wart removers?
Ready to Register Your Wart Remover Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for wart remover products manufacturers worldwide.
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