WARNING LETTER
TKTX USA
MARCS-CMS 698435 —
February 25, 2025
Product:
Drugs
Over-the-Counter Drugs
Recipient:
TKTX USA
United States
admin@tktxusa.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
February 25, 2025
RE: 698435
Dear Sir/Madam:
This letter concerns your firm’s distribution of the drug products “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” “TKTX Gold Numbing Cream 40%,” and “TKTX Yellow Numbing Cream 40%” (hereinafter collectively referred to as “TKTX Numbing Creams”) 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.tktxusa.com, where your products are available for purchase in the United States without a prescription. We also reviewed your social media handles, “TKTX Numbing Cream USA” on Facebook and “tktx.numbingcream” on Instagram, which direct consumers to your website to purchase the products.
“TKTX 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). “TKTX Numbing Creams” 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, 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, 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 to 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 advisories
2
and a recent news release
3
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 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 “TKTX Numbing Creams” 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 Blue Numbing Cream 40%”
“
What is TKTX Blue Numbing Cream?
Blue TKTX Numbing Cream is a topical anesthetic designed to numb the skin surface, effectively reducing pain and discomfort associated with dermal procedures. It is widely used in various cosmetic and medical applications to provide temporary relief from pain and itching.” [from the product website]
“
Ingredients of TKTX Blue Numbing Cream
The primary ingredients typically found in Blue TKTX Numbing Cream include: ∙Lidocaine: An anesthetic that numbs tissue in a specific area. ∙Prilocaine: Another anesthetic that works in conjunction with Lidocaine to increase numbness. ∙ Epinephrine: Helps to reduce bleeding and prolong the duration of the anesthetic effect…” [from the product website]
“Blue TKTX Numbing Cream is used during: ∙Tattoo application and removal. ∙Body piercing. ∙Cosmetic procedures like microblading and lip fillers. ∙Laser hair removal and other laser treatments. ∙Minor surgical procedures and injections…To use Blue TKTX Numbing Cream…2. Apply a generous amount of cream to the skin and spread it evenly. 3. Cover the area with a plastic wrap to enhance absorption. 4. Leave the cream on the skin for approximately 25 to 30 minutes before the procedure. 5. Remove the wrap and wipe away any excess cream before starting the procedure.” [from the product website]
“TKTX Green Numbing Cream 40%”
“
What is TKTX Green Numbing Cream 40%?
TKTX Green Numbing Cream 40% is a topical anesthetic with a potent formula designed to numb the skin effectively. The “40%” indicates the strength of active agents in the cream, which is formulated to provide maximum pain relief for skin procedures that may otherwise be quite painful.” [from the product website]
“
Ingredients of Green TKTX Numbing Cream
The Green TKTX Numbing Cream is composed of several active ingredients, which may include: ∙Lidocaine: A local anesthetic that helps to reduce pain and discomfort. ∙Prilocaine: Another anesthetic that increases the numbing effect when combined with Lidocaine. ∙Epinephrine: Helps to prolong the numbing effect and decrease bleeding and swelling…” [from the product website]
“Green TKTX Numbing Cream is commonly used for: Tattoo application, especially in areas with dense nerve endings. ∙Body piercing procedures. ∙Cosmetic procedures such as microblading and dermal fillers. ∙Laser hair removal and other laser-based skin treatments. ∙Minor surgical procedures that can be performed without deep anesthesia…” [from the product website]
“
TKTX Numbing Cream Variants
TKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are: ∙ Green: This variant has a 40% concentration of lidocaine and is recommended for use on sensitive areas such as the face, neck, and genitals…” [from the product website]
“TKTX Black Numbing Cream 40%”
“
TKTX Black Numbing Cream 40%
Introducing the powerful TKTX Black Numbing Cream, a trusted ally in pain management since its inception. Specially formulated for maximum efficiency, this cream is an ideal solution for easing discomfort associated with a wide range of skin procedures such as tattoos, cosmetic treatments, and laser hair removal. Recognized for its exceptional quality, TKTX Black sets the standard in pain relief, providing a numbing effect that lasts for a full four hours when applied correctly.” [from the product website]
“
TKTX Numbing Cream Variants
TKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are…∙ Black: The black variant contains 25% lidocaine and is ideal for use on smaller areas, such as the fingers and toes…” [from the product website]
“TKTX Gold Numbing Cream 40%
”
“
What is TKTX Gold Numbing Cream 40%?
Gold TKTX Numbing Cream 40% is a highly concentrated topical anesthetic cream that provides significant numbing effects for skin procedures. The “40%” indicates a potent blend of active ingredients designed to deliver an intense level of numbness for an extended period of time, making it suitable for more painful procedures where deep numbing is essential.” [from the product website]
“
Ingredients of TKTX Gold Numbing Cream
The key ingredients in Gold TKTX Numbing Cream usually include: ∙Lidocaine: A numbing agent that provides pain relief by blocking nerve signals in the skin. ∙Prilocaine: Works synergistically with Lidocaine to enhance the numbing effect. ∙Epinephrine: Constricts blood vessels to reduce swelling and bleeding, and prolongs the duration of the anesthetic.” [from the product website]
“Gold TKTX Numbing Cream is typically utilized for: ∙Extensive tattooing sessions. ∙Piercings in sensitive areas. ∙Cosmetic procedures that may cause significant discomfort, such as deep laser treatments and extensive waxing. ∙Minor surgical interventions that do not require injectable anesthesia….” [from the product website]
“
TKTX Numbing Cream Variants
TKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are… ∙Gold: This variant has the lowest concentration of lidocaine at 20% and is recommended for use on thicker skin, such as the palms and soles of the feet.” [from the product website]
“TKTX Yellow Numbing Cream 40%”
“
TKTX Yellow Numbing Cream 40%
…This cream, known for its authentic quality, skillfully alleviates pain and discomfort linked to various skin procedures, including cosmetic treatments, tattoo applications, and laser hair removal. With a standing as a top choice in the realm of pain relief, its effectiveness and quality are evident. When applied as directed, it maintains its numbing effect for up to 04 hours.” [from the product website]
“
TKTX Numbing Cream Variants
TKTX Numbing Cream comes in four different variants, each with its unique color and potency level. They are…∙Yellow: With a 35% concentration of lidocaine, this variant is suitable for use on larger areas of the body, such as the arms and legs…” [from the product website]
Unapproved New Drug Violations
Based on the above labeling evidence “TKTX Numbing Creams” 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 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 “TKTX 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, here M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or the “external analgesics monograph”).
4
However, “TKTX Numbing Creams” do not conform to the conditions of use specified in the external analgesics monograph for the reasons described below.
The combinations and/or concentrations for the active ingredients identified in the labeling for the “TKTX Numbing Creams” do not conform to the conditions of use set forth in M017. Specifically, your labeling purports that “TKTX Green Numbing Cream 40%,” “TKTX Yellow Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” and “TKTX Gold Numbing Cream 40%” have a concentration of lidocaine at 40%, 35%, 25%, and 20%, respectively. These concentrations are above the 0.5% to 4% concentration range of lidocaine permitted in M017. Additionally, these drug products also include lidocaine in combination with other active ingredients that are not permitted in M017. As noted above, your labeling states that “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” and “TKTX Gold Numbing Cream 40%,” are typically composed of lidocaine, prilocaine, and epinephrine. Neither epinephrine nor prilocaine are permitted as active ingredients in M017. Moreover, prilocaine is not a permitted active ingredient in any final administrative order issued in accordance with section 505G.
Furthermore, labeling for all of the “TKTX Numbing Creams” 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 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.
Thus, “TKTX Numbing Creams” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.
5
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
“TKTX 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 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
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
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
4
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).
5
FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “TKTX Blue Numbing Cream 40%,” “TKTX Green Numbing Cream 40%,” “TKTX Black Numbing Cream 40%,” “TKTX Gold Numbing Cream 40%,” and “TKTX Yellow Numbing Cream 40%” 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