TKTX Numb Store

Selected passages from the FDA letter

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

Passage 1

Specifically, lidocaine, the active ingredient in all of these products is at a concentration of 5%. These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted by M017.

Passage 2

Specifically, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]” and “TKTX plus 200% More Volume,” contain lidocaine 5%, prilocaine, and epinephrine as active ingredients. Neither epinephrine nor prilocaine are permitted as active ingredients by M017. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.

Passage 3

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 procedures are not included in M017 or any other final administrative order in accordance with section 505G.

Passage 4

We note that “TKTX plus 200% More Volume” also appears 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

Further, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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.