WoundGelHA (WGHA) is formulated to provide wound care dressing and management. WGHA is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. WGHA has been demonstrated to be of value in the management of certain skin ulcers. Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissues. The sodium hyaluronate present in WGHA is derived from synthetic sources. WGHA [(based on FDA 510(k) K143527)] is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor cites), mechanically or surgically debrided wounds, and for second degree burns.
INSTRUCTIONS FOR USE: WGHA should be applied after the ulcer or wound is cleaned with normal saline solution. Other cleaning agents are not recommended. Debridement (surgical cleaning) of the ulcer or wound may be performed at the discretion of the healthcare professional. Excess moisture should be removed using dry gauze.cWGHA is applied liberally into the cavity of the ulcer or wound and to the surrounding area. After applying WGHA, a non-stick gauze dressing should be placed on the wound site then covered by an occlusive dressing. A gauze dressing should always be placed on the wound after applying WGHA. A self-adhesive bandage or suitable tape adhesive should be wrapped over the non-stick gauze dressing. The entire process of wound cleaning, applying WGHA, the application of a suitable covering and the bandaging of the area should be repeated weekly or as prescribed.
CONTRAINDICATIONS: WGHA is contraindicated in persons with a known hypersensitivity to any of the ingredients in the formulation.
WARNINGS: Prolonged use of the product may give rise to sensitization phenomena. Should this occur, the patient should discontinue use of the product immediately and consult a physician.
PRECAUTIONS & OBSERVATIONS: WGHA is for external use only. If signs of infection become present, consult a physician. Keep this and all medications out of the reach of children.
SUPPORTIVE CARE: Appropriate supportive measures should be taken where indicated (e.g., the use of graduated compression bandaging in the management of venous leg ulcers) or pressure relief measures in the management of pressure ulcers. The control of blood glucose as well as appropriate advice regarding pressure relief measures should be provided to patients with diabetic foot ulcers. Colonization of chronic wounds is common and the use of WGHA is not contraindicated. WGHA may be used on infected wounds under medical supervision and in conjunction with other appropriate therapy and frequent monitoring of the wound by the healthcare professional.
HOW SUPPLIED: WGHA is available in a 1-pack, 1/3 oz. tube (NDC #58407-9925-10) or a 3-pack of 1/3 oz. tubes (NDC #58407-9925-30). Do not use if tamper evident foil seal is broken or missing. Expiry date is located on the crimped end of tube.
STORAGE: Store at room temperature, 15°-30°C (59°-86°F) in a dry place. Do not freeze or expose to temperatures above 30°C (95°F). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. WGHA covered by Patent Nos. 9,821,005 & 10,322,142.