CloSYS® Dry Mouth Sensitive Mouth Rinse

CloSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to relieve symptoms and discomfort of dry mouth by refreshing, moisturizing, hydrating, and lubricating the oral cavity. It is a ready-to-use, non-sterile, semi-viscous clear liquid formulation packaged in 16 FL OZ HDPE bottles with a shelf life of 2 years.

The device is formulated with water, humectants/moisturizers, flavors, sweeteners, and ingredients with lubricating, soothing, and refreshing properties. Key components include xylitol, glycerin, xylitol sorbitol, hydroxyethyl cellulose, disodium phosphate, and sodium phosphate. It has similar properties to predicate Biotene Dry Mouth Oral Rinse, with variations in ingredient concentration and volume to ensure proper dispensing and stability.

ISO 10993 Biological Evaluation of Medical Devices was used for biocompatibility testing. Standard biocompatibility assays including Sensitization, Mucosal Irritation, and Cytotoxicity testing were conducted. Stability testing was performed at room temperature and under accelerated conditions.

The device shares the same intended use and technology as the predicate Biotene Dry Mouth Oral Rinse and reference device Hydris™ Oral Rinse. Although formulation variations exist in ingredient concentration, these do not affect safety profile, function, indications, or efficacy. Biocompatibility testing demonstrates an acceptable safety profile consistent with the predicate, and stability testing confirms product shelf life. The differences in formulation are only to ensure compatibility and proper dispensing, thereby maintaining substantial equivalence.