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
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated March 9, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    For topical use only. Rx only.

  • 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.

  • 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.

  • 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.

  • 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

    BIONECT Cream

    Hyaluronic acid sodium salt, polyethylene glycol 400 monostearate, decyl ester of oleic acid, emulsifying wax, glycerol, sorbitol solution 70%, sodium dehydroacetate, methylparaben, propylparaben, fragrance, purified water.

    BIONECT Gel

    Hyaluronic acid sodium salt, sorbitol solution 70%, sodium dehydroacetate, methylparaben, propylparaben, carbomer 980, sodium hydroxide, purified water.

  • Contraindications

    Do not administer to patients with known hypersensitivity to this product.

  • Interactions

    Do not use concomitantly with disinfectants containing quaternary ammonium salts because hyaluronic acid can precipitate in their presence. The concomitant topical treatment of wounds with antibiotics or other local agents has never given rise to interactions or incompatibilities with BIONECT.

  • Precautions

    Avoid direct contact of container with the affected area. Each container of BIONECT should be used by one patient only in order to reduce the risk of cross infection.

    WARNING

    Keep out of reach of children.

  • Adverse Reactions

    All suspected adverse reactions occurring during the treatment with BIONECT should be reported to your doctor.

  • How Supplied

    BIONECT Cream/Gel is supplied in a:

    25g Cream - 71403-007-02
    100g Cream - 71403-007-04
    100g Gel - 71403-008-04

    Storage

    BIONECT Cream may be stored for up to 24 months, BIONECT Gel may be stored for up to 24 months. Store at room temperature below 86°F (30°C).

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Fidia Farmaceutici S.p.A. - Italy

    Distributed by: EPI Health, LLC
    Charleston, SC 29403
    1-800-499-4468
    www.epihealth.com
    www.Bionect.com

    November 2017

    Bionect and Hyalastine are registered trademarks of Fidia Farmaceutici S.p.A.

    610386/H

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Carton - Cream

    71403-007-04

    Rx Only
    For Topical Use Only

    Bionect®
    (hyaluronic acid sodium salt, 0.2%) Cream

    Net Wt 100g

    Principal Display Panel - 100 g Tube Carton - Cream
  • PRINCIPAL DISPLAY PANEL - 100 g Tube Carton - Gel

    71403-008-04

    Rx Only
    For Topical Use Only

    Bionect®
    (hyaluronic acid sodium salt, 0.2%) Gel

    Net Wt 100g

    Principal Display Panel - 100 g Tube Carton - Gel
  • INGREDIENTS AND APPEARANCE
    BIONECT 
    dressing, wound and burn, hydrogel w/drug and/or biologic
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71403-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hyaluronate sodium (UNII: YSE9PPT4TH) (Hyaluronic acid - UNII:S270N0TRQY) Hyaluronate sodium0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71403-007-041 in 1 CARTON
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    2NHRIC:71403-007-021 in 1 CARTON
    225 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Premarket NotificationK96300402/15/2018
    BIONECT 
    dressing, wound and burn, hydrogel w/drug and/or biologic
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:71403-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hyaluronate sodium (UNII: YSE9PPT4TH) (Hyaluronic acid - UNII:S270N0TRQY) Hyaluronate sodium0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71403-008-041 in 1 CARTON
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Premarket NotificationK97372503/01/2018
    Labeler - EPI Health, Inc (080638894)