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Amazon.com, Inc. was cited for distributing unapproved new drugs and misbranded over-the-counter external analgesic products (tattoo numbing creams) through its Fulfillment by Amazon service, violating sections 505(a) and 502(ee) of the Federal Food, Drug, and Cosmetic Act. The products, including brands such as "Painless Tattoo," "TKTX 40%," and "Nupharmisto," contained active ingredient concentrations exceeding permitted levels for nonprescription external analgesics and were marketed for use before, during, or after cosmetic procedures like tattooing and laser hair removal in ways that could increase skin absorption and safety risks. The FDA noted particular concern that use of these products during cosmetic procedures may occur without professional medical supervision, raising additional safety concerns.