Dermal Source, Inc.

Selected passages from the FDA letter

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

Passage 1

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).

Passage 2

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.

Passage 3

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.

Passage 4

The external analgesic monograph does not permit a combination of more than one “-caine” type active ingredient in a single drug product.

Passage 5

Indications related to tattooing and piercing are not included in M017 or any other final administrative order in accordance with section 505G.

Passage 6

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%.