1. Home
  2. Labeler Index
  3. Wal-mart Stores, Inc.
  4. 49035-231
  5. Label Information: Equate Eye Itch Relief

FDA Label for Equate Eye Itch Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Equate Eye Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, Inc.. 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 of 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 or 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, water for injection


Package/Label Principal Display Panel



NDC 49035-231-10

equate™

Compare to Zaditor® Active ingredient*

Eye Itch Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS

  • •Works in minutes
  • •Original prescription strength
  • •For ages 3 years and older
  • •60 day supply

    • UP TO 12 HOURS

    2 x 10 mL BOTTLES
    (STERILE 0.34 FL OZ EACH)


* Please review the disclaimer below.