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FDA Denies Petition To Pull Teething From OTC Benzocaine Label, Expects Voluntary Changes By Marketers

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

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