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OTC: Nixall™ Wound and Skin Care is intended for over-the-counter use (OTC) of the management of minor skin lacerations, minor abrasions, minor irritations, minor burns and intact skin. Professional Use: Nixall™ Wound and Skin Care is intended to be used under the supervision of a healthcare professional in the management of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post surgical wounds, first and second degree burns, grafted and donor sites. Nixall™ Wound and Skin Care, is intended for over the counter and professional use as follows: - OTC: Nixall™ Wound and Skin Care is for the management of , the irrigation of, the moistening of, and lubrication of minor skin abrasions, minor lacerations, minor burns, minor irritations, minor cuts, and intact skin. Prescription Use: Nixal™ Wound and Skin Care is intended to be used by health care professionals in the management, via debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Nixall™ Wound and Skin Care is a clear solution that aids in the removal of debris and foreign material from the application site. Foreign material and dirt debris are mechanically removed by the action of the wound cleanser moving across the wound bed on the application site with or without the assistance of a suitable wound dressing (i.e. gauze). Nixall™ Wound and Skin Care will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing (spray) inserts and caps. Nixall™ Wound and Skin Care is a clear, hypotonic liquid that helps in the removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are removed by the mechanical action of the fluid moving across the wound bed or application site. Device components are Electrolyzed water 99.5615%, Sodium Chloride (NaCl) 0.4%, Hypochlorous Acid (HOCL) .035% Sodium Hypochlorite (NaOCl) .0035%. The solution preservatives are hypochlorous acid and sodium hypochlorite. The solution contains preservatives to suppress bacterial growth for up to one(1) year after the bottle is opened as referenced by testing in Appendix A in this application.