FDA WARNING_LETTER - Tattoo Numbing Cream Co. - March 25, 2024

The FDA issued a Warning Letter on March 25, 2024, to a firm distributing SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY, following a November 2023 website review. The products are marketed as external analgesics for sensitive cosmetic procedures like tattooing.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and are misbranded under section 502(ee). The firm markets these drugs without an approved application, for indications not covered by the external analgesics final administrative order (M017) under section 505G.

Key violations include: - **Unapproved New Drugs:** The products contain lidocaine concentrations (5%) exceeding the permissible OTC range (0.5%-4%) in M017. - **Impermissible Active Ingredient Combinations:** SIGNATURE TATTOO NUMBING CREAM includes 5% prilocaine and 1% epinephrine. MIRACLE NUMB SPRAY includes 4% prilocaine, 1% epinephrine, propylamine, glycerol, and purified water. M017 does not permit combinations of multiple "-caine" type ingredients or the use of epinephrine, propylamine, glycerol, and purified water as active ingredients. - **Unapproved Indications:** Product claims explicitly market the drugs for tattooing, which is not an indication included in M01