TKTX Store Warning Letter Details

Summary

TKTX Store distributed unapproved new drugs including "Mithra+ 10% Lidocaine," "J-PRO Cream," and other TKTX-branded numbing creams marketed as external analgesics for 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 permissible OTC limits or included active ingredient combinations that did not conform to established conditions for OTC external analgesics. The company marketed and sold these products directly to consumers through its website and Instagram without a prescription, with the FDA documenting the violations through review of product labeling and social media marketing channels.