Label: OPHTHAVET- hyaluronate sodium solution

  • NDC Code(s): 17033-045-10
  • Packager: Dechra Veterinary Products
  • 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 October 28, 2021

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

  • SPL UNCLASSIFIED SECTION

    Sterile Veterinary Ophthalmic Lubricant

    Preservative-Free

    0.18% Viscoadaptive Sodium Hyaluronate

  • CONTAINS:

    Purified water, sodium chloride, glycerol, sodium hyaluronate, sodium dihydrogen phosphate, disodium phosphate, sodium hydroxide

  • INDICATIONS:

    For use as a lubricant to prevent further irritation, or to relieve dryness of the eye. For use in dogs and cats.

  • CAUTION:

    If condition worsens, discontinue use and consult veterinarian. Keep container tightly closed. To avoid contamination, do not touch tip of container to any surface including the eye, the eyelid or your fingers. Replace cap after using. To minimize the risk of infection, DO NOT use beyond the expiry date on the label. Do not use if safety seal is broken. Do not use if cloudy or discolored.

  • DIRECTIONS:

    Apply to the eye as directed by your veterinarian.

    OPHTHAVET Ophthalmic Solution provides blink-activated lubrication and moistening for the eye surface during the day or night.

    • Wash hands before use.
    • Tilt the animal's head up slightly and pull the lower eyelid down to create a small area to apply the drop.
    • While holding the bottle above the eye, press gently to release one drop onto the eye.
    • Repeat the process in the other eye, if needed.
    • After application, shake any remaining droplet from the tip of bottle and replace cap securely. This will help to prevent contamination of the bottle.
    • Can be applied as often as directed by your veterinarian.
    • If you are applying any other eye drops or ointments, wait at least 15 minutes between each application.
  • STORAGE AND HANDLING

    KEEP TIGHTLY CLOSED

    STORE AT 2 - 25°C (36 - 77°F).

  • WARNINGS

    WARNING: KEEP OUT OF REACH OF CHILDREN.

    NOT FOR USE IN HUMANS.

  • HOW SUPPLIED:

    OPHTHAVET Ophthalmic Solution is supplied in a bottle with a fill volume of 10 mL (0.33 fl oz). Contents are sterile and preservative-free.

    NDC: 17033-045-10

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:
    Dechra Veterinary Products
    7015 College Boulevard, Suite 525
    Overland Park, KS 66211 USA
    (866) 933-2472

    OPHTHAVET is a trademark of
    Dechra Veterinary Products, LLC
    © 2021

    Rev. 06/21
    23382400

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    OPHTHAVET™
    Ophthalmic Solution

    Sterile Veterinary
    Ophthalmic Lubricant

    Preservative-Free
    0.18% Viscoadaptive
    Sodium Hyaluronate

    10 mL
    (0.33 fl oz)

    Dechra

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    OPHTHAVET 
    hyaluronate sodium solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:17033-045
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM1.8 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17033-045-101 in 1 CARTON
    110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER09/01/2021
    Labeler - Dechra Veterinary Products (362142734)