Tattoo Numbing Cream Co. Warning Letter Details

Summary

Tattoo Numbing Cream Co. distributed two unapproved external analgesic drug products—SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY—for use before cosmetic procedures without the required FDA application under section 505(a) of the FD&C Act. The products violated FDA regulations by containing lidocaine concentrations exceeding permissible limits for over-the-counter external analgesics and including active ingredient combinations that did not conform with the external analgesics final administrative order under section 505G. Additionally, the products were misbranded under section 502(ee) of the FD&C Act. The FDA identified safety concerns related to the excessive active ingredient concentrations in these formulations marketed through the company's website.