{"description":["Description: HyGel™ is a clear viscous, odorless, aqueous gel principally of sodium hyaluronate and a combination of emollients which together function to maintain tissue hydration and support the healing process. HyGel™ has been demonstrated to be of value in the management of certain skin ulcers and wounds. HyGel™ has also been demonstrated to be of value in the management of various types of dermatoses; including atopic, allergic contact dermatitis, and radio-dermatitis. Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissue. The sodium hyaluronate present in HyGel™ is derived from a bacterial fermentation process. Ingredients: Sodium Hyaluronate (2.5%), hydroxyethyl cellulose, methylparaben, polyethylene glycol, and purified water."],"dosage_and_administration":["Instructions for Use: HyGel™ 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. HyGel™ is applied liberally into the cavity of the ulcer or wound and to the surrounding area. After applying HyGel™, a non-stick gauze dressing (Telfa pad or other suitable non-stick pad) should be placed on the wound site. A gauze dressing should always be placed on the wound after applying HyGel™. A self-adhesive bandage or suitable tape adhesive should be wrapped over the non-stick gauze dressing. The entire process of wound cleaning, applying HyGel™, the application of a suitable covering and the bandaging of the area should be repeated daily. HyGel™ should be applied directly and liberally to contact dermatitis, atopic dermatitis, and radio-dermatitis a minimum of 2-3 times daily."],"effective_time":"20160707","how_supplied":["How Supplied: HyGel™ is available in a unit dose, four pack of 10 gram tubes with tamper evident seal, NDC 15014-105-40."],"id":"70c7ac4b-49b8-4b6c-be9b-bc9f08c4aaec","indications_and_usage":["Indications and Usage: Rx Only Under the supervision of a healthcare professional: HyGel™ is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns. HyGel™ is indicated in the management and relief of burning, itching, and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis."],"openfda":{},"package_label_principal_display_panel":["Packaging Hygelout"],"precautions":["Precautions and Observations: Hygel™ is for external use only. If signs of infection become present, consult a physician. Keep this and all medication out of the reach of children. Pregnancy category C. 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 HyGel™ is not contraindicated. HyGel may be used on infected wounds under medical supervision and in conjunction with other appropriate therapy and frequent monitoring of the wound by a healthcare professional."],"set_id":"80bfa2fe-660e-4904-9e29-c177b25b3f68","spl_product_data_elements":["HyGel Sodium Hyaluronate HYALURONATE SODIUM HYALURONIC ACID HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) METHYLPARABEN POLYETHYLENE GLYCOLS WATER"],"spl_unclassified_section":["Storage: Store at room temperature, 15°-30° C (59°-86°F) in a dry place. Do not freeze or expose to temperatures above 35°C (95°F). HyGel™ is covered by Patent Nos. 5,897,880 • 6,063,405 • 6,120,804 • 6,335,035 HyGel™ is covered by Patent Filing No 14818810 Distributed by: Gentex Pharma Ridgeland, MS 39157 Manufactured by: Laboratorios Andromaco S.A. Boulevard Manuel Avila Camacho No. 88 Torre Picasso, 9th Floor Miguel Hidalgo Postal Code 11000, Mexico DF Phone +52 (55) 9178-7540"],"version":"2","warnings":["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."]}