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Dermal Source, Inc. distributed five unapproved topical anesthetic products (NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1) marketed for use before cosmetic procedures such as tattooing and piercing without an approved new drug application, violating section 505(a) of the FD&C Act. The products were also misbranded under section 502(ee) and contained lidocaine concentrations exceeding permissible limits for over-the-counter external analgesics or included unapproved active ingredient combinations. The FDA identified these violations through a website review conducted in September 2023.