Search Results

Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Hydrolyzed Collagen/Ag Wound Gel for OTC use is a change in label of the previously approved Hydrolyzed Collagen/Ag Wound Gel with Silver (K061227), for Rx use, to permit its use by the general public without the need for a physician's prescription. The proposed Hydrolyzed Collagen/Ag Wound Gel for OTC use is the identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227) with elemental silver as a preservative that reduces the growth of bacteria within the dressing. Hydrolyzed Collagen/Ag Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. The high concentration of hydrolyzed collagen in the gel provides for greater moisture absorption capacity into the gel supporting silver retention within the gel. Hydrolyzed Collagen/Ag Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.

Collagen/Ag Wound Gel is an absorbent wound dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites. Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites

Hydrolyzed Collagen/Ag Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.

For the management of oral wounds and sores, including: - Denture sores - Oral ulcers (non-infected or viral) - Oral dicorp (surgical wounds) - Suture sites - Burns - Extraction sites - Surgical wounds - Traumatic wounds

Not Found

for the indications for use stated in the enclosure

Not Found