FDA WARNING_LETTER - TKTX Company - March 25, 2024

The FDA issued a Warning Letter to the firm for distributing unapproved and misbranded drug products, specifically “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%.” These products, marketed as external analgesics for sensitive cosmetic procedures like tattooing and laser treatments, were found to violate sections 505(a) and 502(ee) of the FD&C Act. The FDA’s review of the firm’s website, tktxcompany.com, revealed that the products do not conform to the conditions of use specified in Over-the-Counter Monograph M017: External Analgesic Drug Products. Key deficiencies include lidocaine concentrations exceeding the permitted 0.5%-4% range, the inclusion of unpermitted active ingredients like epinephrine and prilocaine, and combinations of multiple "-caine" type ingredients not allowed by M017. Furthermore, the products' indications for use, such as for tattooing and laser procedures, are not consistent with M017. The FDA expressed significant 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 preventive measures, or face potential legal action including seizure and injunction.