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FDA Warning Letter Explorer
Drugs · Mar 25, 2024

Tattoo Numbing Cream Co.

9 extracted findings

FDA source excerpt, selected passage

SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB 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
SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB 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
SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB 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.
04
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
SIGNATURE TATTOO NUMBING CREAM identifies 5% prilocaine and 1% epinephrine as additional active ingredients, and MIRACLE NUMB SPRAY identifies 4% prilocaine, 1% epinephrine, propylamine, glycerol, and purified water all as
06
labeling for SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY include indications that are not consistent with the indications for external analgesic drug products.
07
Claims on your SIGNATURE TATTOO NUMBING CREAM product such as “Our Signature Tattoo Numbing Cream is your secret weapon for your next tattoo appointment” and statements on your MIRACLE NUMB SPRAY product such as “[w]hether you forgot to use our Signature Tattoo Numbing Cream or it’s starting to wear off, Miracle Numb Spray is perfect to apply mid-session (even on broken skin). Be sure to get a bottle so you don’t tap out and can finish your tattoo,” go beyond merely describing the general intended uses for an external analgesic drug product.
08
SIGNATURE TATTOO NUMBING CREAM and MIRACLE NUMB SPRAY do not comply with the external analgesic monograph described above, nor are they otherwise marketed in accordance with section 505G.
09
Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C.

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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