WARNING LETTER
TKTX Store
MARCS-CMS 698371 —
February 25, 2025
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Kelly Chan
TKTX Store
391 Sutter Street
San Francisco
,
CA
94108
United States
kelly@tktxstore.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
February 25, 2025
RE: 698371
Dear Ms. Chan:
This letter concerns your firm’s distribution of “Mithra+ 10% Lidocaine,” “J-PRO Cream” and all your TKTX branded numbing products,
1
for use as external analgesics, among other things,
2
prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address https://www.tktxstore.com, where your products are available for purchase in the United States without a prescription. We also reviewed your social media website at “Instagram.com/tktxstore,” which includes a link to your website to purchase the products.
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). These products 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 primarily as external analgesics to be used before and/or during various sensitive cosmetic procedures such as tattooing, laser cosmetic procedures, microblading, 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, the “J-PRO Cream” and the “Mithra+ 10% Lidocaine” drug products include lidocaine concentrations that exceed what is permissible for over-the-counter (OTC) external analgesic and anorectal drug products marketed without an approved application and/or include a combination of active ingredients that does not conform with the conditions of marketing in the external analgesics final administrative order issued under section 505G.
3
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 advisories
4
and a recent news release
5
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
Your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams 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 branded numbing creams
6
“Which to select TKTX numbing cream?. . . Big Size Tattoo Green 40% Lasting 5-8 Hours…Medium Size Tattoo … Yellow 40%, Black 40%, Gold 40% Lasting 4 Hours…Small Size Tattoo…White 39%, Red 38%, Blue 39% Lasting 3-4 Hours” [from website blog at https://www.tktxstore.com/blogs/news/how-to-select-tktx-numbing-cream]
“How Do TKTX Numbing Creams Work? One of the main reasons people avoid getting tattoos is the pain. No one likes pain, but also, many say that beauty is pain, so at the end of the day we’re all just very confused about this concept. However, what if we told you there is a way you can go through the whole tattooing process with the minimum pain and discomfort possible.” [from website blog at https://www.tktxstore.com/blogs/news/why-tktx-doesnt-work-well-to-me]
“Mithra+ 10 Lidocaine”
“Purple 10% Color . . . Mithra numbing cream is used for temporary relief of pain which available (sic) without a prescription. Tattooing without pain anymore. . . Helps to relieve the pain experienced during tattooing, laser hair removal, body piercing, body waxing, bikini waxing, cosmetic tattooing and permanent make up.” [from the product website]
“
Usage:
. . . 1.Wash the area receiving tattoo or lasers treatment with soap and water. . . . 2.Cover Hot towel (sic) in 5 minutes or Apply with alcohol. . . 3.Dry area completely. . . . 4.Cover 2-3 mm thickness (not good effective (sic) if too thin) . . . 5.Seal with Film (Canon plastic wrap) in 45-60 minutes . . . 6.Clean the skin and start tattooing.” [from the product website]
“25 minutes super fast deep numbs, and it will last for 3-5 hours tattooing with no pain.” [from the product website]
“J-PRO Cream”
“Lidocaine Pricaine (sic) Local anesthetics . . . Lidocaine 25 mg+Prilcaine (sic) 25mg . . . 39.9% More Numbing” [from the product website]
“39.9% 10g . . . JRPO Numbing Cream Tattoo Body Deep Anesthetic Fast Numb Cream Semi Permanent Skin Body”
“Used for Eyebrow (sic), eyeliner, lips, face tattoo; permanent cosmetics; tattooing; micro needle pain; body piercing;laser (sic) tattoo removal;laser (sic) hair; removal;waxing;IPL (sic) treatment;electrocautery (sic)” [from the product website]
“Usage: . . . For temporary relief of pain and itching due to anorectal disorders or a local anesthetic for minor surgery or cosmetic procedures. . . . *tattooing & body piercing . . . *body waxing & bikini waxing . . . *laser hair removal . . . *cosmetic tattooing . . . *Micro needle pain, body piercing,(sic) laser tattoo removal,laser hair removal,waxing,permanent (sic) cosmetics,IPL (sic) treatment, electrocautery and so on.” [from the product website]
“How to Use TKTX: . . . 1.Wash (sic) the area receiving tattoo or laser treatment with soap and water. . . . 2.Cover a Hot (sic) Towel (sic) on skin for 5 Minutes ,(sic) Dry area completely. . . . 3.Apply a thick amount of TKTX numbing cream to the area and rub in thoroughly. . . . 4.After rubbing into the skin, apply a 2nd heavy layer of TKTX cream (1/8” or 2-3 mm thick) over the area. . . . 5.Cover the TKTX cream with plastic wrap (saran wrap) and keep warm. The heat under the plastic wrap helps activate the cream and keeps the cream from drying out. . . . 6.Leave TKTX cream (sic) and wrap in place for 25-50 Minutes (sic) before tattoo. For long procedures lasting hours . . . over large areas; apply numbing cream over the entire work area, then remove in sections as procedure progresses. . . . 7.Skin typically remains numb for 3 – 5 hours once cream is removed from numbed skin depending on . . . skin type and location on body.” [from the product website]
Unapproved New Drug Violations
Based on the above labeling evidence your “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams are primarily 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 section 505(a) of the FD&C Act, 21 U.S.C. 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 “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesics monograph”).
7
However, “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and TKTX branded numbing creams do not conform to the conditions of use specified in the external analgesics monograph for the reasons described below.
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. 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.
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. 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, “Mithra+ 10% Lidocaine,” “J-PRO Cream,” and your TKTX branded numbing creams do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.
8
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
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.
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/
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
Your TKTX numbing products include “Deep Numbs TKTX 40% More Numbing” (Green Color), “TKTX 40% More Numbing” (Black Color),” “TKTX 40% More Numbing” (Gold Color),” “Deep Numbs TKTX 40% More Numbing” (Yellow Color), “TKTX 40% More Numbing” (Red Color), “TKTX 39% More Numbing” (Blue Color),” “TKTX 39% More Numbing” (White Color), “TKTX 38% More Numbing” (Red Color), and “TKTX 38% More Numbing” (Gold Color).
2
We note that your TKTX 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 final administrative order, Over-the-Counter Monograph M015: Anorectal Drug Products for Over-the-Counter Human Use. Your TKTX Numbing Creams do not conform to the conditions set forth in this monograph. Your TKTX Numbing Creams are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of both M017 and M015 for the intended use to numb the skin prior to sensitive cosmetic procedures. In addition, according to labeling for your “J-PRO Cream” and “Mithra+ 10% Lidocaine,” both products contain lidocaine as an active ingredient at or above a concentration of 5% and thus cannot meet the requirements of both M017 and M015.
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
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.
5
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
6
The cited claims are attributable to all your TKTX branded numbing creams that are listed in footnote 1.
7
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).
8
FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “Deep Numbs TKTX 40% More Numbing” (Green Color), “Mithra+ 10% Lidocaine” (Black Color), “TKTX 40% More Numbing” (Black Color), “TKTX 40% More Numbing” (Gold Color), “Deep Numbs TKTX 40% More Numbing” (Yellow Color), “TKTX 40% More Numbing” (Red Color), “J-PRO Cream” “TKTX 39% More Numbing” (Blue Color), “TKTX 39% More Numbing” (White Color), “TKTX 38% More Numbing” (Red Color), and “TKTX 38% More Numbing” (Gold Color) are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.
Content current as of:
03/04/2025
Regulated Product(s)
Drugs
Over-the-Counter Drugs