Label: BIONECT FOAM-
- NHRIC Code(s): 68712-046-01
- Packager: Innocutis Holdings LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated September 8, 2014
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Description:
Bionect Foam is a soft white foam, which, at rest, takes the form of a clear, pale yellow liquid. The principal component is the sodium salt of hyaluronic acid (0.2%). The sodium hyaluronate (Hyalastine) is derived from a natural fermentation process. Hyaluronic acid is a biological polysaccharide (glycosaminoglycan) and is a major component of the extracellular matric of the connective tissues.
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Indications:
Bionect is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns, The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction and desiccation.
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Directions:
The wounds or ulcers should be cleaned and disinfected prior to treatment. In the event of long-standing ulcers, it may be advisable to clean and/or to debride the wound by surgical or enzymatic means, prior to treatment. Apply a thin layer of Bionect without extensive rubbing onto the wound surface, two or three times per day. Cover the lesion area with a sterile gauze pad and, if necessary, with an elastic or compressive bandage.
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Warnings:
If conditions worsens, consult your physician immediately. Keep this product out of the reach of children. The prolonged use of the product may give rise to sensitization phenomena. Should this happen, discontinue the treatment and follow a suitable therapy. Do not use the product after expiration date reported on the package.
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Storage:
Please store Bionect at room temperature. Bionect Foam may be stored for up to 24 months under these conditions. Store at room temperature below 86F (30C).
Manufactured for: Fidia Farmaceutici S.p.A - Italy
Distributed by: Innocutis Holdings, LLC
Charleston SC 29401
800-499-4468
www.innocutis.com
www.bionect.com
U.S. Pat. No.: 5,925,626
- Packaging:
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INGREDIENTS AND APPEARANCE
BIONECT FOAM
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:68712-046 Inactive Ingredients Ingredient Name Strength HYALURONIC ACID (UNII: S270N0TRQY) 0.2 WATER (UNII: 059QF0KO0R) BUTANE (UNII: 6LV4FOR43R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) PROPANE (UNII: T75W9911L6) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68712-046-01 1 in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K973722 09/08/2014 Labeler - Innocutis Holdings LLC (451549861)