OTC Benzocaine Needs Label Warning, Indication Change – Public Citizen

In a citizen petition the group asks FDA to remove teething for children 2 years and older as an indication for some benzocaine products and require a label warning for OTC monograph benzocaine products concerning the risk of methemoglobinemia.

Allowing firms the option of including a label warning about potential methemoglobinemia risk from OTC benzocaine oral care products is not enough, Public Citizen argues in a citizen petition to substantially change the product labels.

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