Loading…
TKTX Numbing Cream USA distributed four unapproved external analgesic products (Yellow, White, Gold, and Black formulations at 40% concentration) for use prior to cosmetic procedures without an approved New Drug Application, violating sections 505(a) and 301(d) of the FD&C Act. The products were found to contain lidocaine concentrations exceeding permissible OTC limits and/or ingredient combinations that did not conform to the FDA's external analgesics final administrative order under section 505G. Additionally, the products were misbranded under section 502(ee) of the FD&C Act, as they were marketed with unapproved indications for cosmetic procedures such as tattooing, laser treatments, and microblading.