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TKTX USA distributed five numbing cream products (TKTX Blue, Green, Black, Gold, and Yellow Numbing Cream 40%) for use before cosmetic procedures such as tattooing and microblading without FDA approval, violating sections 505(a) and 301(d) of the FD&C Act. The products were also misbranded under section 502(ee) and contained lidocaine concentrations exceeding what is permitted for over-the-counter external analgesics, with active ingredient combinations that do not conform to FDA's external analgesics final administrative order. The company marketed these unapproved drugs directly to consumers via their website (www.tktxusa.com) and social media accounts (Facebook and Instagram) without a prescription requirement.