FDA Label for Eye Itch Relief

View Indications, Usage & Precautions

Eye Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Safeway. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Ketotifen 0.025%


Purpose



Antihistamine

(equivalent to ketotifen fumarate 0.035%)


Uses



For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.


Warningsfor External Use Only



Do not use

  • •if you are sensitive to any ingredient in this product
  • •if solution changes color or becomes cloudy
  • •to treat contact lens related irritation
  • When using this product

    • •remove contact lenses before use
    • •wait at least 10 minutes before re-inserting contact lenses after use
    • •do not touch tip of container to any surface to avoid contamination
    • •replace cap after each use

Stop Use And Ask A Doctor If



you experience any of the following:

  • •eye pain
  • •changes in vision
  • •redness of the eyes
  • •itching that worsens or lasts for more than 72 hours

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and children 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor


Other Information



Store at 4-25°C (39-77°F)


Inactive Ingredients



Benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.


Questions?



Call: 1-800-553-5340

*This product is not manufactured or distributed by Novartis, distributor of Zaditor.


Package/Label Principal Display Panel – 5Ml Carton



NDC 21130-601-05

Signature™
Care

Quality Guaranteed

STERILE
ORIGINAL PRESCRIPTON STRENGTH

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
Antihistamine Eye Drops

Compare to the active ingredient in Zaditor*

Up to 12 hours


0.17 FL OZ (5mL)


* Please review the disclaimer below.