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Amazon.com distributed four unapproved drug products intended to treat molluscum contagiosum (Naturasil Molluscum Treatment Kit, Conzerol 2 Step Treatment, ZymaDerm for Molluscum, and HealthyDerm Molluscum Contagiosum Treatment) through its Fulfillment by Amazon service, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were unapproved new drugs with no legally marketed over-the-counter alternatives for treating molluscum contagiosum, a viral skin infection that requires professional medical evaluation to rule out serious conditions such as skin cancer or fungal infections. Amazon was responsible for introducing or delivering these drugs into interstate commerce without FDA approval, making the company liable for the distribution of these products.