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WARNING LETTER

March 25, 2024

RE: 3017200845

Dear Ms. Haake:

This letter concerns your firm’s distribution of the drug products, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 for use as external analgesics prior to sensitive cosmetic procedures. The United States Food and Drug Administration (FDA) reviewed your website in September 2023 at the Internet address https://dermalsource.com/, where these products are available for purchase.

Based on our review, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 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). NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 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, among other things,¹ 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.²

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 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 advisories³ 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

NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 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://dermalsource.com/ and your social media account on 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:

    NEW AND IMPROVED BLUE GEL:

    “Drug Facts . . . Uses . . . Temporarily relieves pain and swelling due to tattooing, permanent makeup, or other pain sensitive procedures. . . . Directions: . . . Apply sparingly to broken skin and cover with occlusive dressing. Product is ineffective when applied to intact skin.” [from your product website https://dermalsource.com/shop/new-improved-blue-gel/]

    “Dermal Source’s New & Improved Blue Gel . . . for use during a pain sensitive procedure. . . . This product combines two topical anesthetics with a vascular constrictor for reduction of swelling, bruising and bleeding. This is the anesthetic of choice for fast onset and reduction of swelling in areas such as lips or inner arms, where bruising and bleeding are a problem.” [from your product website https://dermalsource.com/shop/new-improved-blue-gel/]

    “. . . for maximum comfort and minimal bleeding. . . . New & Improved Blue Gel is back and better then [sic] ever. This product can be occluded and is effective for up to two hours with one application. Great for eyeliner, lips, eyebrows, tattoos, piercing, laser/dermabrasion, electrologist. Reduces swelling as well. . . . #permanetmakeup [sic] #tattoo . . .” [from your Instagram social media account
https://www.instagram.com/p/CiLD8m3LZ_A/]

    SUPERIOR SUPER JUICE:

    “Dermal Source’s Superior Super Juice is a liquid-based topical anesthetic . . . for use during a pain sensitive procedure. This powerful triple anesthetic is safe for use on all procedures except eyeliner. . . . Superior Super Juice is also a highly effective secondary anesthetic for use during painful procedures. It is fast-acting and powerful yet has no burn on open skin contact. . . . During Procedure Anesthetic . . . Apply to opened skin . . .” [from your product website https://dermalsource.com/shop/superior-super-juice/]

    “This powerful liquid anesthetic . . . is for use during procedures. It contains 5% Lidocaine, 1% Tetracaine and 12% Benzocaine. It is safe for use on all procedures except eyeliner. . . . Superior Super Juice is also a highly effective secondary anesthetic for use during painful procedures. It is fast-acting and powerful yet has no burn on open skin contact.” [from your website https://dermalsource.com/wp-content/uploads/H-Superior-Super-Juice.pdf]

    PREMIUM PRO PLUS:

    “Dermal Source’s Premium Pro Plus . . . for use before a pain sensitive procedure. . . . This cream . . . is safe for eyeliner. . . . Uses: . . . Temporarily relieves pain due to tattooing or other pain sensitive procedures.” [from your product website https://dermalsource.com/shop/premium-pro-plus/]

    FIVE-STAR VASOCAINE:

    “Drug Facts . . . Uses . . . Temporarily relieves pain, itching or swelling associated with anorectal disorders or pain sensitive procedures. . . . Directions . . . Wash Vasocaine off completely before tattooing.” [from your FIVE-STAR VASOCAINE product label]

    “Dermal Source’s Five-Star Vasocaine is a liquid-based topical anesthetic . . . for use during a pain sensitive procedure. It is ineffective on intact skin. It is safe for use on all procedures except eyeliner. It also contains a vascular constrictor to reduce swelling and bleeding. Five-Star Vasocaine is a highly effective secondary anesthetic for use during painful procedures. It is fast-acting and has no burn when applied to open skin.” [from your product website https://dermalsource.com/shop/five-star-vasocaine/]

    “. . .This product is highly effective on broken skin. Use Five-Star Vasocaine during tattooing, piercing, or other broken skin procedures. . . .Because of the added ingredient of a vascular constrictor, you will also experience a reduction in bruising and bleeding with this product.” [from your website https://dermalsource.com/wp-content/uploads/H-Five-Star-Vasocaine.pdf]

    “Dermal Source has some amazing anesthetics that keep me in the chair longer. Vasocaine liquid anesthetic not only works fast but has a vascular constrictor that reduces bleeding and swelling . . . #tattoo #tattooartist . . . #tattoolife #tattooart . . .” [from your Instagram social media account https://www.instagram.com/p/CHsuSFHFBvF/]

    MAXIMUM ZONE 1:

    “Uses: . . . Temporarily relieves pain associated with anorectal disorders, or in preparation for other pain sensitive procedures such as lasers, electrolysis, tattooing or piercing. . . . Active Ingredients: . . . Lidocaine HCI 5% (Topical Anesthetic) . . .” [from your product website
https://dermalsource.com/shop/maximum-zone-1/]

    “This product is for the relief of discomfort due to anorectal disorders, or in preparation for other pain sensitive procedures such as lasers, electrolysis, tattooing or piercing.” [from your website https://dermalsource.com/wp-content/uploads/H-Maximum-Zone-1.pdf]

Your NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 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, your products 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 NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 do not conform to the conditions of use set forth in M017. Specifically, lidocaine hydrochloride, an active ingredient labeled to be in all these products, is listed as lidocaine hydrochloride 5%. This concentration is above the 0.5% to 4% concentration range of lidocaine hydrocholoride permitted by M017. Furthermore, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, and PREMIUM PRO PLUS also include a combination of lidocaine hydrocholoride and tetracaine hydrocholoride as active ingredients in the same drug product and SUPERIOR SUPER JUICE also contains benzocaine in addition to lidocaine and tetracaine. The external analgesic monograph does not permit a combination of more than one “-caine” type active ingredient in a single drug product.

Furthermore, labeling for NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 include indications that are not consistent with the indications for external analgesic drug products. Claims on your products described above related to the temporary relief of pain and swelling due to tattooing, permanent makeup, or other pain sensitive procedures go beyond merely describing the general intended uses for external analgesic drug products. Indications related to tattooing and piercing are not included in M017 or any other final administrative order in accordance with section 505G.⁴ 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, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 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).

Misbranded Drug Violations

Further, FIVE-STAR VASOCAINE, MAXIMUM ZONE 1, NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, and PREMIUM PRO PLUS are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they 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

_____________________

1 We note that your FIVE-STAR VASOCAINE and MAXIMUM ZONE 1 products 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 products do not conform to the conditions set forth in this monograph. Your products are labeled as both external analgesics and anorectal products. Your products cannot meet the requirements of M017 or M015 with lidocaine HCl as an active ingredient at or above a concentration of 5%.

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 FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1 are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.