Amazon.com, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Examples of claims from the product labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following: Painless Tattoo: Tattoo Numbing Cream: “PAINLESS TATTOO: TATTOO NUMBING CREAM ALL GAIN NO PAIN TOPICAL ANESTHETIC .

Passage 2

We note that the “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” and “QWP: Painless Tattoo” products also appear to be indicated to relieve pain associated with anorectal disorders.

Passage 3

Additionally, labeling for “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” includes indications that are not permitted indications for external analgesic drug products under M017.50(b).

Passage 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.

Passage 5

Thus, “Painless Tattoo: Tattoo Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” do not comply with the applicable conditions specified in M017 and have not otherwise been found GRASE.

Passage 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 an approved application.

Passage 7

Because there are no approved applications in effect for these products, these products are unapproved new drugs.

Passage 8

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.

Passage 9

“Painless Tattoo: Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” 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 subject of applications approved under section 505 of the FD&C Act, 21 U.S.C.

Passage 10

The labeled concentrations and/or combinations for the active ingredients identified in product labeling for “Painless Tattoo: Numbing Cream,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” do not conform to the conditions of use set forth in M017.

Passage 11

Specifically, lidocaine, an active ingredient labeled to be in all these products, is listed as lidocaine 5% or lidocaine hydrochloride 5% in all of these products except for “Painless Tattoo: Tattoo Triple Numb.” This concentration is

Passage 12

Furthermore, “Painless Tattoo: Numbing Cream” includes a combination of lidocaine, prilocaine, and epinephrine as active ingredients in the same drug product; “Painless Tattoo: Tattoo Triple Numb” includes a combination of lidocaine, tetracaine, and benzocaine as active ingredients in the same drug product

Passage 13

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,” “Ink Scribd: Numbing Cream,” “Nupharmisto: Tattoo Numbing Cream,” “QWP: Painless Tattoo,” “Kaisasa: Tattoo Numbing Cream,” “Painless Tattoo: Tattoo Triple Numb,” and “TKTX 40%” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).