Label: BIONECT-
- NHRIC Code(s): 68712-007-01, 68712-007-02, 68712-007-03, 68712-007-04
- Packager: Innocutis Holdings LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated September 21, 2012
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- Description
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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 operatice 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 the 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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Warning
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.
- Ingredients
- Contraindication
- Drug Interactions
- Precautions
- Adverse Reactions
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How Supplied
Bionect Cream is supplied in a:
25g cream Tube - NHRIC 68712-0007-02
50g Cream Tube - NHRIC 68712-0007-03
60g Cream Tube - NHRIC 68712-0007-04
Manufactured for: Inncoutis Holdings LLC, Charleston SC 29401
1-800-499-4468 www.Innocutis.com, www.Bionect.com
Manufactured by: Fidia Farmacutici S.p.A, Italy
U.S. Pat. No.: 5,925,626 - Storage
- Carton
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INGREDIENTS AND APPEARANCE
BIONECT
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:68712-007 Inactive Ingredients Ingredient Name Strength HYALURONIC ACID (UNII: S270N0TRQY) .2 g in 1 g PEG-8 STEARATE (UNII: 2P9L47VI5E) DECYL OLEATE (UNII: ZGR06DO97T) WHITE WAX (UNII: 7G1J5DA97F) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITOL (UNII: 506T60A25R) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68712-007-01 3 g in 1 TUBE 2 NHRIC:68712-007-02 25 g in 1 TUBE 3 NHRIC:68712-007-03 50 g in 1 TUBE 4 NHRIC:68712-007-04 100 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K963004 04/01/2004 Labeler - Innocutis Holdings LLC (451549861)