Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a topical hydrogel containing hypochlorous acid applied to skin and wound areas to maintain a moist environment and facilitate wound healing. It is marketed in both over-the-counter formulation for minor skin injuries and prescription formulation for more serious dermal lesions, pressure ulcers, and burns.

The device is an opaque, aqueous-based topical hydrogel with hypochlorous acid and sodium hypochlorite as preservatives that inhibit microorganism growth. It contains viscosity-enhancing agents to impart hydrogel characteristics and is supplied non-sterile in various packaging configurations. The formulation is biocompatible and conforms to USP <51> preservative effectiveness standards.

ISO 10993-5 (in-vitro cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-10 (irritation and skin sensitization), ISO 10993-18 (chemical characterization), ISO 10993-23 (irritation tests), USP <51> (antimicrobial effectiveness), and USP <85> (bacterial endotoxins).

The Nixall device is substantially equivalent because it uses identical technology to the Puracyn® Plus predicate devices—both are aqueous hydrogels with hypochlorous acid and sodium hypochlorite preservatives that maintain moist wound environments and encourage autolytic debridement. The intended uses are essentially identical for both OTC and prescription applications, covering the same wound types and healing mechanisms. Biocompatibility testing demonstrates equivalent biological safety, and preservative effectiveness testing shows equivalent antimicrobial performance per USP <51>.