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DermaRite Industries, LLC received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in New Jersey, making its drug products adulterated and unfit for commerce. Five specific OTC products—DermaSeptin Ointment Skin Protectant with Cooling Menthol, Lantiseptic Moisture Shield Original Skin Protectant, DermaMed Ointment Skin Protectant, DermaFungal Antifungal Cream with 2% Miconazole Nitrate, and PeriGiene Health Care Antiseptic—were identified as unapproved new drugs introduced into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. Additionally, several products were cited as misbranded under sections 502(f)(1) and 502(ee) of the FD&C Act, indicating deficiencies in manufacturing methods, facilities, and controls.