FDA WARNING_LETTER - TKTX Numb Store - March 04, 2025

On February 25, 2025, the FDA issued a Warning Letter to a firm distributing "TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]," "TKTX plus 200% More Volume," and "TKTX RAPID NUMB & LONG LASTING" via www.tktxnumbstore.com. These products, marketed as external analgesics for sensitive cosmetic procedures like tattooing and piercing, are deemed unapproved new drugs and misbranded.

The violations include: 1. **Unapproved New Drugs:** The products are not generally recognized as safe and effective (GRASE) and lack FDA approval. They do not conform to the Over-the-Counter (OTC) Monograph M017 for external analgesics. * **Lidocaine Concentration:** All products contain 5% lidocaine, exceeding the M017 permissible range of 0.5% to 4%. * **Unauthorized Active Ingredients:** "TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]" and "TKTX plus 200% More Volume" contain prilocaine and epinephrine, which are not permitted by M017 or any other 505G final administrative order. * **Unapproved Indications:** Labeling claims for tattooing, piercing, and laser cosmetic procedures are