FDA WARNING_LETTER - TKTX USA - March 04, 2025

The FDA issued a Warning Letter to the firm distributing "TKTX Numbing Creams" (Blue, Green, Black, Gold, Yellow 40%) for use as external analgesics before cosmetic procedures. The FDA reviewed product labeling, website (www.tktxusa.com), and social media.

The products are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and misbranded under section 502(ee). They are marketed without an approved application and for indications not covered by a final administrative order under section 505G.

Violations include lidocaine concentrations exceeding the 0.5% to 4% range permitted in the OTC external analgesics monograph (M017). Specifically, products claim 20-40% lidocaine. Additionally, "TKTX Blue, Green, and Gold Numbing Cream 40%" contain prilocaine and epinephrine, which are not permitted active ingredients in M017 or any other 505G order. The products' indications for tattooing, piercing, and laser cosmetic/surgical procedures are also not consistent with M017.

The FDA has safety concerns due to potential increased absorption of active ingredients through irritated or broken skin, especially without professional supervision, which can lead to serious injury.

The firm must notify the FDA in writing within 15 working days of