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Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions

AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.

For the management of open wounds. Indications: For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.

Amerigel™ Ointment Saturated Wound Dressing