sky bank media, llc – FDA Warning Letter, Mar 26, 2024

On March 25, 2024, the FDA issued a Warning Letter to Mr. Burbank regarding the distribution of PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY. An FDA website review in November 2023 found these products, marketed as external analgesics for sensitive cosmetic procedures, to be unapproved new drugs and misbranded.

The products are considered unapproved new drugs because they are marketed without an approved application under section 505(a) of the FD&C Act and do not conform to the conditions of the external analgesics final administrative order (M017) under section 505G. Specifically, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY contain lidocaine at 5%, exceeding the M017 permitted range of 0.5% to 4%. Additionally, they include prilocaine (5% and 4% respectively) and epinephrine (1% in both), which are not permitted active ingredients in M017. The products' labeling also includes indications for tattooing, cosmetic procedures, and piercing, which are not consistent with M017.

The FDA expressed safety concerns due to the potential for increased absorption of active ingredients through irritated or broken skin, especially given unsupervised use. The products are also misbranded under section 502(ee) because they are nonprescription drugs