Indelicare DBA INKEEZE

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 3

The labeled concentration for the active ingredient identified in product labels for INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL do not conform to the conditions of use set forth in M017. Specifically, lidocaine HCl and lidocaine are active ingredients labeled to be in INK EEZE B NUMB NUMBING SPRAY BLACK LABEL and INK EEZE B NUMB NUMBING GEL, respectively, at a concentration of 5%. This concentration is above the 0.5% to 4% concentration range of both lidocaine and lidocaine HCl permitted by M017.

Passage 4

Furthermore, labeling for INK EEZE Original B NUMB NUMBING GEL, INK EEZE B NUMB NUMBING SPRAY BLACK LABEL, and INK EEZE B NUMB NUMBING FOAM SOAP include indications that are not consistent with the indications for external analgesic drug products. Claims on your products described above related to the temporary relief of pain due to tattooing go beyond merely describing the general intended uses for external analgesic drug products. Indications related to tattooing are not included in M017, or any other final administrative order in accordance with section 505G***5***. We note that these products also appear to be indicated to relieve pain associated with anorectal disorders. OTC anorectal drug products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. Indications related to tattooing and piercing are not included in M015.

Passage 5

Your INK EEZE Original B NUMB NUMBING GEL and INK EEZE B NUMB NUMBING SPRAY BLACK LABEL are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 with lidocaine or lidocaine HCl as an active ingredient at or above a concentration of 5%.

Passage 6

Additionally, INK EEZE B NUMB NUMBING FOAM SOAP also appears to be indicated to decrease bacteria on the skin. Under 505G(a)(3) of the FD&C Act, OTC consumer antiseptic drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements. Your product does not conform to the conditions set forth in the most recent applicable proposal.