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IBSPOT.com Inc. distributed unapproved new drugs—"Taoscare Motion Sickness Patch" and "Navabelle Motion Sickness Patches"—in violation of the Federal Food, Drug, and Cosmetic Act. FDA testing confirmed the products contained undisclosed active ingredients (diphenhydramine, diphenhydramine N-oxide, and diclofenac) not listed on product labels, making them both unapproved new drugs under section 505(a) and misbranded drugs under section 502(a). The company marketed these products through its website www.ibspot.com with disease claims including "Anti-Nausea Fast" and "72h LONG EFFECT," establishing their intended use as drugs without FDA approval.