FDA WARNING_LETTER - indelicare - March 26, 2024

The FDA issued a Warning Letter to Messrs. Ether and Hoy regarding the distribution of INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP. An FDA website review in November 2023 found these products marketed as external analgesics for sensitive cosmetic procedures like tattooing.

The products are deemed unapproved new drugs under section 505(a) of the FD&C Act and misbranded under section 502(ee). Violations include marketing without an approved application and for indications not covered by a final order under section 505G. Specifically, INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL contain 5% lidocaine, exceeding the 0.5% to 4% concentration permitted by the Over-the-Counter Monograph M017 for external analgesics. Furthermore, claims related to tattooing and piercing are not included in M017 or M015 (Anorectal Drug Products). The FDA expressed safety concerns due to potential increased absorption through irritated or broken skin, especially given unsupervised use.

The firm must notify the FDA in writing within fifteen working days of corrective actions taken, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure