Wart Remover
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.
Back to previous pagePopular Pages
- FDA Registration Certificate
- FDA Drug Listing Renewal
- FDA Registration Renewal
- U.S. FDA Agent Requirements
- FDA Agent Services
- OTC Monograph Number Search
- Export Certificates
- FDA Certificate to Foreign Government (CFG)
- Certificate to Pharmaceutical Product (CPP)
- FDA Registration & US Agent Fees
- FDA OTC Drug Facility Registration Fees 2024
- FDA Drug Reporting - Amount of Listed Drugs
LIBERTY MANAGEMENT GROUP LTD.
75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : +1 (630) 270-2921
Fax : +1 (815) 986-2632
E-mail : info@fdahelp.us