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."