FDA WARNING_LETTER - TKTX Numbing Cream USA - March 04, 2025

The FDA issued a Warning Letter to the firm distributing "TKTX Numbing Creams" (Yellow, White, Gold, and Black TKTX Numbing Cream 40%) for violations of the Federal Food, Drug, and Cosmetic Act. The products, marketed as external analgesics for use before cosmetic procedures like tattooing and microblading, are considered unapproved new drugs and misbranded.

The FDA reviewed the product labeling, including the website www.tktxnumbingcreamusa.com. The violations stem from the products being marketed without an approved application under section 505 of the FD&C Act and not conforming to the conditions of marketing for nonprescription external analgesic drug products under section 505G. Specifically, the products contain lidocaine at 5%, exceeding the 0.5% to 4% permitted in the OTC monograph M017. Additionally, "Gold TKTX Numbing Cream 40%" and "Black TKTX Numbing Cream 40%" contain prilocaine, which is not permitted in any OTC drug monograph. The products' indications for tattooing, piercing, and laser cosmetic procedures are also not included in M017.

The FDA expressed safety concerns due to the potential for increased absorption of active ingredients through irritated or broken skin, especially given unsupervised use. The firm must respond within 15 working days, detailing corrective actions and prevention measures, or provide reasoning if they believe no violation