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Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical 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, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions.

OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.

revyve® Antimicrobial Skin and Wound Cleanser is a clear, colorless liquid containing poloxamer 407, EDTA, sodium citrate/citric acid, polyhexanide (PHMB) and glycerol. PHMB at a concentration of 0.1% w/w is added as preservative to prevent microbial growth, within the product during shelf-storage. This skin and wound cleanser will be packaged in 4 fluid oz (118.3 mL) polyethylene squeeze bottle. revyve® Antimicrobial Skin and Wound and Cleanser will be used for mechanically cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, first and superficial second-degree burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt, debris, and microorganisms. It will be provided in non-sterile form, labeled for single patient, single use only.

The device will be available as both a Rx and OTC product.

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