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FDA Warning Letter Explorer
Drugs · Mar 25, 2024

Sky Bank Media, LLC dba Painless Tattoo Cream Co.

7 extracted findings

FDA source excerpt, selected passage

PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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).
02
PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).
03
These products are marketed without an approved application under section 505 of the FD&C Act for indications that are not included in a final administrative order issued under section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application.
04
Furthermore, your drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic drug products marketed without an approved application and/or include combinations of active ingredients that do not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.
05
Specifically, lidocaine, an active ingredient labeled to be in both of these products, is listed as lidocaine 5%. This concentration is above the 0.5% to 4% concentration range of lidocaine permitted by M017.
06
In addition, these drug products also include a combination of lidocaine and other active ingredients that are not permitted by M017. Specifically, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY identify prilocaine 5% with epinephrine 1%, and prilocaine 4% with epinephrine 1%, respectively, as additional active ingredients. However, neither epinephrine nor prilocaine are permitted as active ingredients in M017.
07
Furthermore, labeling for PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY include indications that are not consistent with the indications for external analgesic drug products. Claims on your PAINLESS TATTOO NUMBING CREAM product such as, “OTHER USES FOR PAINLESS TATTOO…- Tattoo Removal - Microblading - Laser Hair Removal - Permanent Cosmetics - Waxing - Injections - Piercings - Lip Fillers - Blood Tests - Vaccinations” and statements on your PAINLESS TATTOO NUMBING SPRAY product such as, “OTHER USES FOR PAINLESS TATTOO SPRAY…- Tattoo Removal - Microblading - Permanent Cosmetics…” go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing, cosmetic procedures, and piercing are not included in M017 or any other final administrative order in accordance with section 505G.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 201.12821 CFR 330

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