Mentholatum seeks advisory committee review of analgesic patches/pads.
This article was originally published in The Tan Sheet
Executive Summary
MENTHOLATUM REQUESTS OTC ADVISORY PANEL REVIEW OF ANALGESIC PADS/PATCHES to discuss "scientific and legal issues" related to such products. In an Aug. 4 citizen petition to FDA, Mentholatum noted that the status of pad and patch OTC external analgesic products is "an industry-wide issue that has never been properly addressed in the external analgesic rulemaking." FDA should first reopen the administrative record for OTC external analgesics and then "submit the issue to the OTC advisory panel for evaluation," the company asserted.