Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCentura Pharmaceuticals Inc marketed "BLT 1-2-3 Cream," an unapproved topical analgesic drug product sold over-the-counter without FDA approval, violating section 505(a) of the Federal Food, Drug & Cosmetic Act. The product was also misbranded under section 502(ee) of the FD&C Act. FDA identified safety concerns regarding the use of this lidocaine-containing external analgesic before cosmetic procedures, where unsupervised application over large skin areas could increase systemic absorption and cause serious injury, particularly given FDA's prior warnings about "-caine" type ingredients applied under conditions that enhance skin penetration.