Skincare OTC

Products with claims to treat skin such as Acne, Skin Lightening, and other types of skin treatments are classified as over-the-counter products and regulated as drugs by the United States Food and Drug Administration. These products can only be manufactured by an OTC licensed manufacturing facility. FMK Labs has been an FDA registered drug manufacturer for 9 years with a combined experience of over 100 years in OTC formulations. Our experienced QC & Regulatory team ensures your product meets the latest in FDA regulations, and also are able to your handle all FDA paperwork, clearances and registration submissions as a an additional service.