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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. DO NOT USE
    5. WHEN USING THIS PRODUCT
    6. OTC - STOP USE
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. OTC - QUESTIONS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens. 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.


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

Otc - Stop 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.


Otc - Questions



Questions or comments?

Toll Free Product Information

Call: 1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2013 Walgreen Co.

MADE IN U.S.A.

ITEM 306486

9323100

FU60107


Package Label.Principal Display Panel



Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

  • •Works in minutes
  • •For ages 3 years & older
  • •30-day supply

    • 0.17 FL OZ (5 mL)

    12 UP TO 12 HOURS

    Compare to Zaditor® active ingredient‡‡


* Please review the disclaimer below.