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The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of: - Pressure sores - Diabetic ulcers - Leg ulcers - Donor sites and graft sites - Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns - Trauma wounds Over-The-Counter Use (21 CFR 801 Subpart C): - The gel-e Bandage may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - Abrasions - Lacerations

Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal. The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.