OTC Firms Try Again For Benzocaine Monograph Status
This article was originally published in The Tan Sheet
Executive Summary
Labels for benzocaine-containing oral analgesics would include pictograms in the Drug Facts box to show consumers how much product to use, under a proposal by the Consumer Healthcare Products Association
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FDA says benzocaine-containing oral analgesic manufacturers will have to conduct a larger clinical trial to support a Category I (safe and effective) classification for the treatment of toothaches
Benzocaine Monograph For Toothache Requires Further Study – FDA
FDA says benzocaine-containing oral analgesic manufacturers will have to conduct a larger clinical trial to support a Category I (safe and effective) classification for the treatment of toothaches