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  5. Label Information: Eye Itch Relief

FDA Label for Eye Itch Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF YOU EXPERIENCE ANY OF THE FOLLOWING:
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?

Eye Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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%
(equivalent to ketotifen fumarate 0.035%)


Purpose



Antihistamine


Uses



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


Warnings



For 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
    • •if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    • •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, water for injection


Questions Or Comments?



[phone icon]Call: 1-800-632-6900

DISTRIBUTED BY
THE KROGER CO., CINCINNATI, OHIO 45202
PRODUCT OF ITALY

*Systane® and Zaditor® are registered
trademarks of Alcon, Inc., Fribourg,
Switzerland CH-1701. Alcon, Inc. is not
affiliated with The Kroger Co. or this product.

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800-632-6900
www.kroger.com


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