Pediculicide Drug Products
The FDA oversees OTC lice treatments, known as pediculicide drug products, through a specific monograph designated as M031. This monograph outlines the criteria that manufacturers must follow to ensure their products are safe and effective for treating head, pubic, and body lice. M031 dictates acceptable ingredients, proper labeling with directions and warnings, and manufacturing standards. Following this monograph allows lice treatments to be sold over-the-counter without a prescription. Examples of common monograph-approved ingredients include pyrethrins, which kill lice and their eggs. If a lice treatment contains unapproved ingredients or deviates from the monograph requirements, it would be classified as a new drug.
Pediculicide - Active Ingredients and OTC Monograph Number
| Active Ingredients | OTC Monograph Number |
|---|---|
| Pyrethrum extract (providing a concentration of pyrethrins of 0.17 to 0.33 percent) with piperonyl butoxide | M031.10 (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