Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

OTC BOIL TFM MOVES SIX INGREDIENTS TO CATEGORY III (MORE STUDY) FROM CATEGORY II

Executive Summary

The tentative final monograph (TFM) for OTC boil remedies reclassifies magnesium sulfate, benzocaine, camphor, ichthammol, juniper tar and phenol to Category III. Published in the Jan. 26 Federal Register, the TFM also places sulfur, which was not included in the original panel report, as a Category III ingredient for boils. The panel report, published in 1982, classified 24 ingredients as Category II based on the OTC review panel's recommendations. The TFM explains that the panel did not review specific ingredients but placed all of the ingredients in Category II "because of its belief that the self-treatment of boils is not desirable because improper treatment or a delay in receiving proper professional treatment may cause the infection to spread." Commerce Drug was the only drug company to submit comments on the panel report. The company markets an OTC boil product, Boil-Ease, that contains several of the reclassified ingredients. FDA explained that it is reclassifying the six ingredients based on data in Commerce's submission and data that had been submitted to the OTC review panel for boil products. Studies cited by Commerce Drug, "show that human skin is remarkably resistant to staphylococcal and streptococcal infection," the TFM states. Therefore, "the agency believes that a safety concern that infection may spread may not be a major problem." However, the TFM adds, "the agency concludes that additional information is needed before the agency can fully address the panel's concerns that improper treatment or a delay in receiving professional treatment for boils may cause the infection to spread."
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS013110

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel