Label: I-DEFENSE VET- hyaluronate sodium ointment
- NDC Code(s): 13105-0290-1
- Packager: I-MED PHARMA
- 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.
Updated July 29, 2020
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- SPL UNCLASSIFIED SECTION
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.
- 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.
- 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
- HOW IT'S SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 g Tube Carton
INGREDIENTS AND APPEARANCE
hyaluronate sodium ointment
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:13105-0290 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hyaluronate Sodium (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) Hyaluronate Sodium 20 mg in 5 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13105-0290-1 5 g in 1 TUBE 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)