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OTC pediculicide drug products final monograph

This article was originally published in The Tan Sheet

Executive Summary

Amended to clarify that labeling for OTC lice treatments containing active ingredient pyrethrum extract should "provide a specified concentration range of pyrethrins in a formulated product," FDA announces in the Aug. 13 Federal Register. The final monograph is revised to read: "The active ingredients of the product consist of the combination of pyrethrum extract (providing a concentration of pyrethrins of .17% to .33%) with piperonyl butoxide (2% to 4%) in a non-aerosol dosage formulation." Previously, the monograph had said "pyrethrum extract (.17% to .33%)." The change was requested by NDMA in October 1996. FDA published the OTC pediculicide final monograph in December 1993...
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