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WARNING LETTER

TKTX Numb Store MARCS-CMS 697051 —

Product:
Drugs
Recipient:
TKTX Numb Store

United States

service@tktxnumbstore.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

February 25, 2025

RE: 697051

Dear Sir/Madam:

This letter concerns your firm’s distribution of the drug products “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” indicated for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address www.tktxnumbstore.com where the products are available for purchase in the United States without a prescription.

“TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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). “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” 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, among other things,1 to be used before and/or during various sensitive cosmetic procedures such as tattooing, piercing, laser cosmetic 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, these 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.2

FDA has safety concerns about these 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 advisories3 and a recent news release4 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 and Misbranded Drug Violations

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

Examples from the product labeling, including the website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not limited to, the following:

“TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub]”

“TOPICAL ANESTHETIC CREAM” [from the product website]

“DRUG FACTS…Active Ingredient…Lidocaine 5%, Prilocaine, Epinephrine…Local Anesthetic…Uses: For the temporary relief of ■ TATTOOING ■ PIERCING ■ PERMANENT MAKEUP ■ LASER TREATMENTS ■ WAXING ■ MESO PROCEDURES” [from the product website]

“TKTX plus 200% More Volume”

“Active ingredients - Lido5%,Prilo, Epine…Uses – For the temporary relief the discomfort of ∙ TATTOOING ∙ PIERCING ∙ PERMANENT MAKEUP ∙ LASER TREATMENTS ∙ WAXING ∙ MESO PROCEDURES” [from the product website]

“…Best for minor cuts, minor scrapes, minor burns, insect bites, anorectal disorder” [from the product website]

“Helps Reduce Inflammation - Enriched with Vitamin E, your TKTX topical helps relieve swelling. your TKTX topical helps relieve swelling…”[from the product website]

“TKTX RAPID NUMB & LONG LASTING”

“FAST PAIN RELIEF” [from the product website]

“Topical Anesthetic Cream” [from the product website]

“5% LIDO TOPICAL CREAM MAXIMUM STRENGTH…APPLY-Great for tattoos, tattoo removals, piercings and laser waxing” [from the product website]

Unapproved New Drug Violations

Based on the above labeling evidence “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” are intended for use as external analgesic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.
Under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to nonprescription external analgesic drug products, such as “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesic monograph”).5 However, “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not conform to the conditions of use specified in the external analgesic monograph for the reasons described below.

The combinations and/or concentrations of the active ingredients identified in the product labeling for “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not conform to the conditions of use set forth in M017. 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.

Additionally, these drug products also include lidocaine in combination with other active ingredients that are not permitted by M017. 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.

Furthermore, the labeling for TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” include indications that are not consistent with the indications for external analgesic 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 procedures are not included in M017 or any other final administrative order in accordance with section 505G.

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. 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 TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.6 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without and approved application. Because there are no approved applications in effect for these products, they are unapproved new drugs. The 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).

Misbranded Drug Violations

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.

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 these 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 these 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/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

______________________

1 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 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 M015: Anorectal Drug Products for Over-the-Counter Human Use. This product does not conform to the conditions set forth in this monograph. “TKTX plus 200% More Volume” is labeled as both an external analgesic and anorectal drug product. This product cannot meet the requirements of both M017 and M015 with lidocaine or lidocaine HCl as an active ingredient at or above a concentration of 5% nor with a combination of active ingredients of lidocaine, prilocaine, and epinephrine. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.

2 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).

3 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.

4 Refer to the March 26, 2024 news release titled, “FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects,” see https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-topical-pain-relief-products-due-potential-dangerous-health.

5 M017 reflects the conditions as set forth in the relevant final order established and in effect under section 505G; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf).

6 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination “TKTX TOPICAL ANESTHETIC CREAM 5% Lidocaine [TKTX Tub],” “TKTX plus 200% More Volume,” and “TKTX RAPID NUMB & LONG LASTING” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

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