I-DEFENSE VET: Product Information

I-DEFENSE VET- hyaluronate sodium ointment
I-MED PHARMA

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.

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.

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
(click image for full-size original)

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.

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 g0.18 oz

PRINCIPAL DISPLAY PANEL -- 5 g Tube Carton
(click image for full-size original)
I-DEFENSE VET hyaluronate sodium ointment
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13105-0290
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hyaluronate Sodium (HYALURONIC ACID) Hyaluronate Sodium 20 mg in 5 g
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13105-0290-1 5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/25/2020
Labeler — I-MED PHARMA (249008772)

Revised: 07/2020 I-MED PHARMA

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2020. All Rights Reserved.