Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSeeNext Venture, Ltd. distributed three unapproved NumbSkin lidocaine numbing cream products (5% and 10.56% formulations) marketed as external analgesics for cosmetic procedures including tattooing, piercing, and laser hair removal without FDA approval, violating section 505(a) of the FD&C Act. The products were also misbranded under section 502(ee) of the FD&C Act, with lidocaine concentrations exceeding permissible limits for over-the-counter external analgesic products. The FDA identified these violations through a website review in October 2023 and found the products were being distributed into interstate commerce without required New Drug Application approval or compliance with nonprescription drug regulations under section 505G.