TKTX Store – FDA Warning Letter, Mar 4, 2025

On February 25, 2025, the FDA issued a Warning Letter to Ms. Chan regarding the distribution of "Mithra+ 10% Lidocaine," "J-PRO Cream," and all TKTX branded numbing products. These products are marketed as external analgesics for use before sensitive cosmetic procedures like tattooing and microblading, and are sold without a prescription via tktxstore.com and Instagram.

The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act, and are misbranded under section 502(ee). The products are considered drugs due to their intended use for pain relief and affecting body function.

Key violations include: - **Unapproved New Drugs:** The products lack FDA approval and do not conform to the Over-the-Counter (OTC) monograph M017 for external analgesics or M015 for anorectal drug products. - **Unapproved Indications:** Claims for tattooing, piercing, and laser cosmetic procedures are not included in any OTC monograph. - **Excessive Active Ingredient Concentrations:** "Mithra+ 10% Lidocaine" exceeds permissible lidocaine concentrations. "J-PRO Cream" combines lidocaine and prilocaine, which is not permitted. TKTX products contain prilocaine (not an acceptable OTC ingredient) and epinephrine at concentrations not