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WARNING LETTER

March 25, 2024

RE: 3027980112

Dear Sir/Madam:

This letter concerns your firm’s distribution of the drug products “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your website at the internet address https://tktxcompany.com/, where these products are available for purchase.

Based on our review, “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” 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). “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).

Your firm markets the above listed drug products as external analgesics to be used before and/or during various sensitive cosmetic procedures such as tattooing, laser cosmetic procedures, permanent makeup procedures, and others. 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. 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.¹

FDA has safety concerns about your external analgesic drug products, which include certain active ingredients at concentrations that exceed levels currently permitted in such nonprescription drug products, because they are intended to be used before or during certain cosmetic procedures that could lead to increased absorption of the drug product through the skin. FDA is aware that use of these products before and/or during a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin. FDA has specifically warned in multiple public health advisories2 about the use of similar lidocaine and other “-caine” type ingredient products when applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time, and when the skin is covered after application. These uses increase the amount of active ingredient that passes into the bloodstream and, if used improperly, may cause serious injury.

Unapproved New Drug Violations

“TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as topical external analgesic drug products for pain-sensitive cosmetic procedures.

Examples of claims observed on the product labeling, including your product website https://tktxcompany.com/, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but are not limited to, the following:

“TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER”

    “Drug Facts…Active Ingredient Lidocaine 22% Epinephrine 0.02% …Uses…Local anesthesia of the skin. Such as: Tattoo, Piercing, Permanent Makeup, Microdermabrasion, IPL Treatment, Fractional Co2 Laser, Laser Tattoo Removal, Mole Wart Removal, Dermaroller, Hair Removal, As well as pain relief during various small epidermal surgeries.” [from your product label]

    “Features…Its innovative formula has been specially developed to provide a more effective numbing experience. The new formulation of TKTX Numb Black 95% marks a milestone in the industry, incorporating carefully selected ingredients to ensure maximum relief from the sensation of pain. Its effectiveness is supported by a unique combination of anesthetic agents, delivering remarkable results across various applications.” [from your TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER product website]

    “Versatile Application: The New TKTX Numb Black 95% Original is versatile and suitable for a wide range of procedures, including tattoos, laser treatments, waxing, and more. Its adaptability makes it an indispensable tool for professionals in various medical and aesthetic fields.” [from your TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER product website]

“Mithra+ 10% Lidocaine”

    "Features…Mithra+ Numbing Cream Original 10% with Lidocaine offers effective pain relief for various aesthetic procedures. With an advanced formula containing 10% lidocaine, this anesthetic cream provides rapid comfort during tattoos, laser hair removal and other treatments.” [from your Mithra+ 10% Lidocaine product website]

    “Usable Range…Micro Needie [sic] Pain, Tattooing, Body Piercing, Laser Tattoo Removal, Laser Hair Removal Waxing, Permanent Cosmetics.” [from your product label]

    “Ingredients: Lidocaine 10%, Prilocaine 5%, Epinephrine 1%, Cream Base…” [from your product label]

“TKTX During Procedure Numbing Gel 40%”

    "Features…TKTX Gel 15 ML 40% Numbing is an innovative solution for effective pain relief during dermatological and aesthetic procedures. With a potent 40% concentration of active ingredients, this numbing gel offers an advanced approach to minimizing discomfort associated with tattoos, laser hair removal and other treatments. [from your TKTX During Procedure Numbing Gel 40% product website]

    “Usage direction…TKTX Gel is a 0.5oz gel anesthetic that contains a vascular constrictor to reduce swelling and bleeding during procedures. It is a powerful anesthetic that is SAFE FOR USE IN ALL TYPES OF BROKEN SKIN PROCEDURES.” [from your outer container product label]

    “This product contains 8% lidocaine and 2% tetracaine, together with a vascular constrictor which reduces swelling, bruising and bleeding. This makes it the anesthetic of choice for fast onset and reduction of areas such as lips or inner arms, where bruising and bleeding are a problem.” [from your outer container product label]

“J-CAIN cream [LIDOCAINE] 29.9%”

    "Features…J-Cain Cream 29.9% Lidocaine offers advanced pain relief for various skin procedures, crafted for precision and comfort. With a potent Lidocaine concentration, it swiftly alleviates pain in tattoos, piercings, and laser treatments… Precision-designed, it targets specific areas for localized pain management.” [from your J-Cain Cream [Lidocaine] 29.9% product website]

    “In summary, J-Cain Cream 29.9% Lidocaine Original. represents a significant advancement in pain management during dermatological and aesthetic procedures.” [from your J-Cain Cream Lidocaine Original product website]

Your “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” drug products are external analgesic drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G(a)(1) of the FD&C Act, 21 U.S.C. 355h(a)(1), certain nonprescription drugs marketed without an approved application may be legally marketed if they meet applicable requirements. With respect to OTC external analgesic drug products, such products are deemed to be generally recognized as safe and effective (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 M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesic monograph”).³ However, “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” do not conform to the conditions of use specified in the external analgesic monograph for the reasons described below.

The labeled combinations and/or concentrations for the active ingredients identified in product labels for “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in all of these products, is labeled at a concentration of 22% in “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” 10% in “Mithra+ 10% Lidocaine,” 8% in “TKTX During Procedure Numbing Gel 40%,” and 29.9% in “J-CAIN cream [LIDOCAINE] 29.9%.” These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted by M017. Additionally, these drug products also include lidocaine in combination with other active ingredients that are not permitted by M017. Specifically, “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER” identifies lidocaine 22% and epinephrine 0.02%⁴ as active ingredients and “Mithra+ 10% Lidocaine” identifies lidocaine 10%, prilocaine 5%, and epinephrine 1% 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. Furthermore, “TKTX During Procedure Numbing Gel 40%” lists lidocaine in combination with tetracaine 2%. While tetracaine is a permitted active ingredient in M017 at a concentration range of 1% to 2%, M017 does not permit a combination of more than one “-caine” type active ingredient in a single drug product.

In addition, labeling for “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” include indications that are not consistent with the indications for external analgesic drug products. For example, claims on your “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER” drug product such as, “Local anesthesia of the skin. Such as: Tattoo, Piercing, Permanent Makeup, Microdermabrasion, IPL Treatment, Fractional Co2 Laser, Laser Tattoo Removal, Mole Wart Removal, Dermaroller, Hair Removal, [a]s well as pain relief during various small epidermal surgeries,” and claims on your “TKTX During Procedure Numbing Gel 40%” drug product such as, “This numbing gel is specifically designed to reduce pain and bleeding during the PMU or tattoo procedure. It may be used on eyebrows, lips and all other sensitive areas during PMU, microblading or tattooing…” go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing and laser cosmetic procedures are not included in M017 or any other final administrative order in accordance with section 505G.⁵ As stated in the introduction to this letter, we have safety concerns related to the use of these products for these indications due to the potential for greater absorption of the active ingredients through irritated or broken skin.

Thus, “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” do not comply with the external analgesic monograph described above, and they are not otherwise marketed in accordance with section 505G. Therefore, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p) and are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Misbranding Violations

“TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” 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 subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

Jill Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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1 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC external analgesic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf).

2 Refer to FDA public health advisories Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures, Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions, and Improper Use of Skin Numbing Products Can Be Deadly.

3 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC external analgesic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.)

4 We note that your “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER” product label lists epinephrine at a concentration of 0.02% and your product website lists epinephrine at a concentration of 2% However, regardless of the concentration, epinephrine is not permitted as an active ingredient by M017.

5 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “TKTX Numb MAXIMUM STRENGTH PAIN RELIEVER,” “Mithra+ 10% Lidocaine,” “TKTX During Procedure Numbing Gel 40%,” and “J-CAIN cream [LIDOCAINE] 29.9%” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.