Label: BIONECT- hyaluronate sodium
BIONECT- hyaluronate sodium
- NHRIC Code(s): 71403-007-04, 71403-007-02, 71403-008-04
- Packager: EPI Health, Inc
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
Drug Label Information
Updated March 9, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Product Description
BIONECT Cream is a white, viscous cream. BIONECT Gel is a clear, colorless gel. 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 matrix of 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 condition 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 the expiration date reported on the package or if the package is damaged.
- Ingredients
- Contraindications
- Interactions
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- Adverse Reactions
- How Supplied
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 g Tube Carton - Cream
- PRINCIPAL DISPLAY PANEL - 100 g Tube Carton - Gel
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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:71403-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hyaluronate sodium (UNII: YSE9PPT4TH) (Hyaluronic acid - UNII:S270N0TRQY) Hyaluronate sodium 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) decyl oleate (UNII: ZGR06DO97T) white wax (UNII: 7G1J5DA97F) glycerin (UNII: PDC6A3C0OX) 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:71403-007-04 1 in 1 CARTON 1 100 g in 1 TUBE; Type 0: Not a Combination Product 2 NHRIC:71403-007-02 1 in 1 CARTON 2 25 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K963004 02/15/2018 BIONECT
dressing, wound and burn, hydrogel w/drug and/or biologicProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:71403-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hyaluronate sodium (UNII: YSE9PPT4TH) (Hyaluronic acid - UNII:S270N0TRQY) Hyaluronate sodium 0.2 g in 1 g Inactive Ingredients Ingredient Name Strength sodium dehydroacetate (UNII: 8W46YN971G) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) Carbomer homopolymer type c (allyl pentaerythritol crosslinked) (UNII: 4Q93RCW27E) Sodium hydroxide (UNII: 55X04QC32I) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71403-008-04 1 in 1 CARTON 1 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K973725 03/01/2018 Labeler - EPI Health, Inc (080638894)