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Indelicare, operating as INKEEZE, distributed three numbing products (INK EEZE Original B NUMB Numbing Gel, B NUMB Numbing Spray Black Label, and B NUMB Numbing Foam Soap) as unapproved new drugs in violation of section 505(a) of the FD&C Act, marketed for use as external analgesics prior to cosmetic procedures like tattooing without FDA approval. The products were also found to be misbranded under section 502(ee) of the FD&C Act, and at least two of the products contained lidocaine concentrations that exceeded permissible levels. The FDA identified these violations following a website review in November 2023 of inkeeze.com, where the products were available for purchase.