Label: I-DEFENSE VET- hyaluronate sodium ointment

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 29, 2020

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  • SPL UNCLASSIFIED SECTION

    LONG-LASTING HYDRATION
    AND LUBRICATION

    Isotonic Ophthalmic Ointment Containing
    0.4% Sodium Hyaluronate

    MAXIMUM RELIEF

  • INDICATIONS

    I-DEFENSE® VET is a long-lasting hydrating and lubricating ointment for the eye surface. I-DEFENSE® VET is recommended for use in species such as dogs, cats, horses and other animals. I-DEFENSE® VET's viscous nature enables a prolonged adhesion to the ocular surface, performing its moisturizing and protective action even during the night hours.

  • DIRECTIONS

    • Wash your hands well before you use I-DEFENSE® VET.
    • When opening I-DEFENSE® VET, do not use the first delivery of the ointment which may be aqueous. Gently squeeze the tube until the ointment begins to come out.
    • Tilt the head of your companion animal up a little and pull the lower lid of its eye downwards to form a pouch.
    • Hold the tube vertical to the eye.
    • Press the tube gently to release a small quantity of I-DEFENSE® VET on the eye. Repeat the process on the other eye.
    • Apply a small quantity of ointment, preferably at night.
    • If an additional daily dose is required, apply a small quantity of ointment every three or four hours or according to your veterinarian's instructions.
    • Please take care that the tube tip does not touch anything, including the eye or your fingers.
    • Close the cap properly and tightly after use.
  • COMPOSITION

    I-DEFENSE® VET tube contains 5 g of sterile, isotonic ophthalmic ointment whose formulation consists of sodium hyaluronate, sodium chloride, vaseline oil, vaseline, monobasic potassium phosphate, potassium sorbate, disodium phosphate, lanolin alcohol, water and sodium hydroxymethylglycinate.

  • WARNINGS

    • Do not use I-DEFENSE® VET in case of known hypersensitivity or allergy to any of the components.
    • In case of ocular irritation, stop using I-DEFENSE® VET ointment and consult your veterinarian for advice.
    • After application, your companion animal may experience a foreign body sensation which passes after several blinks.
    • Do not use I-DEFENSE® VET if the package is damaged.
    • Do not use I-DEFENSE® VET after expiry date.
    • For use within 8 weeks of opening.
    • Store away from direct heat, in a cool, dry place at a temperature ranging from 9°C to 25°C (48°F to 77° F).
    • Do not ingest.
    • Do not use I-DEFENSE® VET on more than one companion animal.
    • If you are using any other eye drops or ointments, leave about fifteen minutes between each application. It is recommended that you use I-DEFENSE® VET last.
    • Do not use I-DEFENSE® VET in case of ocular lesions or active infection.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    NOT FOR USE IN HUMANS.

  • HOW IT'S SUPPLIED

    I-DEFENSE® VET is supplied in a tube with a fill of 5 g (0.18 oz). Contents are isotonic and sterile.

    Image

    STORE BETWEEN 9°C-25°C (48°F-77°F).

    FOR USE WITHIN 8 WEEKS OF OPENING.

    DO NOT USE BEYOND EXPIRY DATE (⌛).

    I-DEFENSE®VET is a registered trademark of I-MED Pharma Inc.
    2019 I-MED Pharma Inc.

  • SPL UNCLASSIFIED SECTION

    REF: 290
    I-DVOPI 0519
    imedanimalhealth.com

    Manufactured in Italy for:
    I-MED ANIMAL HEALTH
    1601 St-Regis Blvd.
    Dollard-des-Ormeaux, QC
    Canada H9B 3H7
    T (514) 685-8118
    info@imedanimalhealth.com

  • PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

    I-DEFENSE®
    VET

    Isotonic Ophthalmic Ointment
    Containing 0.4% Sodium Hyaluronate

    FOR SEVERE
    DRY EYE

    MAXIMUM
    RELIEF

    Instant, Long-Lasting
    Hydration and
    Lubrication

    Night Time Use

    I-MED
    ANIMAL HEALTH
    5 g
    0.18 oz

    PRINCIPAL DISPLAY PANEL - 5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    I-DEFENSE VET 
    hyaluronate sodium ointment
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13105-0290
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hyaluronate Sodium (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) Hyaluronate Sodium20 mg  in 5 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13105-0290-15 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/25/2020
    Labeler - I-MED PHARMA (249008772)