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FDA Benzocaine Safety Alert Also Targets Pain From Public Citizen Complaint

Executive Summary

FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.

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

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.

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

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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