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Ingrown toenail monograph

This article was originally published in The Tan Sheet

Executive Summary

Sodium sulfide 1% gel is safe, effective for OTC use in treating pain and discomfort associated with ingrown toenails, according to final rule published in 1May 7 Federal Register. Rule creates a new monograph for OTC ingrown toenail relief products in which sodium sulfide 1% is the first ingredient. FDA stipulates gel be used with a retainer ring system to keep product at the area of application, as suggested in the agency's October 2002 proposed rule (2"The Tan Sheet" Oct. 7, 2002, p. 14). Schering-Plough submitted data on the safety of the retainer ring in October 1998; the firm has said in the past it plans to market a sodium sulfide product under its Dr. Scholl's foot care brand. Schering may introduce a product within 30 days of the final rule's publication...
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