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NAW Alution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, postsurgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor burns, superficial abrasions and minor irritations of the skin. NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

The subject device of this submission is NAWAlution Skin and Wound Cleanser for prescription and OTC use. NAWAlution is a clear, colorless liquid intended for the management of wounds. The solution is applied by spraying it directly onto the affected area and/or the dressing. As a result of mechanical action of the solution moving across the wound bed foreign objects, foreign debris and exudate, including, dirt, debris, and microorganisms, are removed from the wound. Moistening and cleansing a wound, such as by using NAWAlution, allows for the natural healing process to take place. NAWAlution for prescription use is supplied in an 8 fluid oz. (237 mL) or 16 fluid oz. (473 mL) spray bottle with a plunger-activated pump applicator. NAWAlution for over-the-counter is supplied in a 50 mL (1.8 fluid oz.) spray bottle with a plunger-activated pump applicator. The solution contains cocamidopropylbetaine, hydrochloric acid, PHMB, zinc/iron, and purified water.