Corn and Callus Remover Drug Products
The U.S. Food and Drug Administration (FDA) regulates over-the-counter (OTC) corn and callus remover products through a specific monograph, designated as M030. This monograph ensures these products are safe and effective for their intended use. According to M030, an acceptable corn and callus remover will be a topical treatment containing salicylic acid within a certain concentration range. The monograph dictates two acceptable dosage forms: a plaster vehicle containing 12% to 40% salicylic acid, or a collodion-like solution with 12% to 17.6% salicylic acid.
Corn and Callus Remover - Active Ingredients and OTC Monograph Number
| Active Ingredients | OTC Monograph Number |
|---|---|
| Salicylic acid 12 to 40 percent in a plaster vehicle | M030.10 (Part 358) |
| Salicylic acid 12 to 17.6 percent in a collodion-like vehicle | M030.10 (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