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Talk to a SpecialistTalk to a SpecialistSinsin Pharmaceutical Co., Ltd. was cited for distributing two unapproved OTC pain relief drug products—SINSINPAS AREX INSTANT PAIN RELIEF and SINSINPAS Pain Relieving Liquid MULPAS—through their website and Amazon storefront without FDA approval, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The products were also found to be misbranded under section 502(ee) of the FD&C Act, as they made drug claims without the required regulatory authorization. The company promoted these products through their website, social media channels on Facebook and Instagram, and directed consumers to purchase them without prescription, despite lacking the necessary new drug applications.