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WARNING LETTER

March 25, 2024

RE: 3028005436

Dear Mr. Burbank:

This letter concerns your firm’s distribution of the drug products, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your website in November 2023 at the Internet address https://painlesstattoo.co/, where these products are available for purchase.

Based on our review, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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). PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY are also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). These violations are described in more detail below. 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, during, and/or after various sensitive cosmetic procedures such as tattooing, piercing, laser/dermabrasion, electrology, 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 products, because they are intended to be used before or during certain cosmetic procedures in ways 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

PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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 external analgesic drug products for pain-sensitive cosmetic procedures.

Examples of claims observed on the product labeling, including your product website https://painlesstattoo.co and your social media accounts on Facebook and Instagram, 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:

    PAINLESS TATTOO NUMBING CREAM:

    “Tattoo Numbing Cream All Gain No Pain Topical Anesthetic;” “Drug Facts . . . Suggested Use . . . For the temporary relief of pain associated with itching, swelling, inflammation or discomfort… Directions: . . . Apply a generous amount of cream to the desired area, wrap area with plastic wrap, wait 45 minutes for full effect.” “We Numb ▪ You Relax…” [from your product label]

    “No Pain, All Gain. Get Tattooed Without ANY Pain…STOP PAIN - Our Painless Tattoo Numbing Cream relieves pain anywhere it's applied for 3+ hours…MULTIPLE USES - As this product is a topical agent and used to numb skin, it can be used for other applications such as laser hair removal, tattoo removal, cosmetic tattooing etc. Directions: …-- Cover with plastic wrap...FAQ… OTHER USES FOR PAINLESS TATTOO…- Tattoo Removal - Microblading - Laser Hair Removal - Permanent Cosmetics - Waxing - Injections - Piercings - Lip Fillers
- Blood Tests - Vaccinations” [from your product website https://painlesstattoo.co/products/painless-tattoo-numbing-cream]

    “Painless Tattoo Cream Directions… Cover with cling film…As Painless Tattoo Cream begins to wear off, apply Painless Tattoo Spray to any areas already worked on for immediate relief throughout the rest of the session…We recommend using Painless Tattoo Spray on broken skin, as needed, for the remaining duration of the tattoo session that outlasts the cream.” [from your product website https://painlesstattoo.co/pages/directions-of-use]

    “Get tattooed without any pain…For those addicted to the art, not the pain…You also deserve the EASIEST sessions ever with the best numbing TOOLS in the game.” [from your Facebook social media account https://www.facebook.com/painlesstattoocream]

    “Reduce tattoo pain…We make tattoo clients happy by eliminating pain” [from your Instagram social media account https://www.instagram.com/p/Cq80lDcvYNp/]

    PAINLESS TATTOO NUMBING SPRAY:

    “Tattoo Numbing Spray All Gain No Pain Fast Acting Topical Anesthetic;” “Drug Facts . . . Suggested Use . . . For the temporary relief of pain associated with itching, swelling, inflammation or discomfort… “Directions: …You may reapply if necessary to continue anesthesia.” “Tattoos ▪ Burns ▪ First Aid ▪ Pain Relief” [from your product label]

    “No Pain, All Gain. Get Tattooed Without ANY Pain…You (or your client) will be completely pain-free, FAST…For use during the tattoo where skin is already broken…Directions: …-- Intended for use on broken skin…-- Spray modestly on the area for which pain relief is desired….-- Wait a few minutes to measure the numbing effect… FAQ… OTHER USES FOR PAINLESS TATTOO SPRAY…- Tattoo Removal - Microblading - Permanent Cosmetics - Burns - Wounds - Itching” [from your product website https://painlesstattoo.co/products/painless-tattoo-numbing-spray]

    “Painless Tattoo Spray Directions… Painless Tattoo Spray is intended for use on broken skin. As Painless Tattoo Cream begins to wear off, apply Painless Tattoo Spray to any areas already worked on for immediate relief throughout the rest of the session…Painless Tattoo Spray will keep the area numb for 1-3 hours depending on your skin type and location on the body.” [from your product website https://painlesstattoo.co/pages/spray-directions-of-use]

    “Get tattooed without any pain…For those addicted to the art, not the pain…You also deserve the EASIEST sessions ever with the best numbing TOOLS in the game.” [from your Facebook social media account https://www.facebook.com/painlesstattoocream]

    “Reduce tattoo pain…We make tattoo clients happy by eliminating pain” [from your Instagram social media account https://www.instagram.com/p/Cq80lDcvYNp/]

Your PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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”). However, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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 PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY do not conform to the conditions of use set forth in M017. Specifically, lidocaine, an active ingredient labeled to be in both of these products, is listed as lidocaine 5%. This concentration is above the 0.5% to 4% concentration range of lidocaine permitted by M017. In addition, these drug products also include a combination of lidocaine and other active ingredients that are not permitted by M017. Specifically, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY identify prilocaine 5% with epinephrine 1%, and prilocaine 4% with epinephrine 1%, respectively, as additional active ingredients. However, neither epinephrine nor prilocaine are permitted as active ingredients in M017.

Furthermore, labeling for PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY include indications that are not consistent with the indications for external analgesic drug products. Claims on your PAINLESS TATTOO NUMBING CREAM product such as, “OTHER USES FOR PAINLESS TATTOO…- Tattoo Removal - Microblading - Laser Hair Removal - Permanent Cosmetics - Waxing - Injections - Piercings - Lip Fillers - Blood Tests - Vaccinations” and statements on your PAINLESS TATTOO NUMBING SPRAY product such as, “OTHER USES FOR PAINLESS TATTOO SPRAY…- Tattoo Removal - Microblading - Permanent Cosmetics…” go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to tattooing, cosmetic procedures, and piercing 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, PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY do not comply with the external analgesic monograph described above, and they are not otherwise marketed in accordance with section 505G.³ 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

PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY 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 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that PAINLESS TATTOO NUMBING CREAM and PAINLESS TATTOO NUMBING SPRAY are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.