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SeeNext 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.