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CofixRx, LLC marketed CofixRX Nasal Spray, a non-alcohol-based antiseptic product, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was also found to be misbranded under sections 502(a) and (ee) of the FD&C Act, and its introduction into interstate commerce was prohibited. The FDA took this enforcement action during the COVID-19 public health emergency to protect consumers from unapproved products making unsupported disease claims.