Sky Bank Media, LLC dba Painless Tattoo Cream Co. Warning Letter Details

Summary

Sky Bank Media, LLC distributed unapproved external analgesic drugs—Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray—for use before cosmetic procedures like tattooing and piercing without an FDA-approved 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 not conforming to established marketing conditions. The company marketed these products on its website without proper regulatory authorization or required labeling compliance under section 502(ee) of the FD&C Act.