Drugs · Feb 25, 2025

TKTX Store

7 extracted findings

FDA source excerpt, selected passage

Your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

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Your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products 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 subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Labeling for the distributed “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams include indications that are not consistent with the indications for external analgesic or anorectal drug products. Claims from the product labeling described above related to tattooing, piercing, and laser cosmetic procedures go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing, piercing, and laser cosmetic or surgical procedures are not included in M017 or any other final administrative order in accordance with section 505G.

Furthermore, the concentration of active ingredients purported in the product formulation identified in the website labeling for the “Mithra+ 10% Lidocaine” drug product includes a lidocaine concentration that is not permitted by M017.

In addition, the “J-PRO Cream” drug product includes lidocaine in combination with prilocaine, which is not permitted in M017 or any final administrative order issued in accordance with section 505G.

Your TKTX branded numbing creams are labeled to contain the active ingredients lidocaine, prilocaine, and epinephrine at various strengths. No OTC drug monograph includes prilocaine as an acceptable active ingredient and epinephrine is only permitted in Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use at concentrations between 0.005 to 0.01 percent.

We note that your TKTX branded numbing creams 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 M015. Indications related to tattooing and piercing are not included in M015.

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

21 CFR 201.12821 CFR 330

TKTX Store

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