Label: EYE ITCH RELIEF- ketotifen fumarate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 28, 2025

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  • 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 ...
  • 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 ...
  • 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 - : 1-800-910-6874
  • Package/Label Principal Display Panel
    NDC 11673-064-05 - Compare to Systane - ZADITOR active ingredient* Eye Itch - Relief - ketotifen fumarate - ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS - For Ages 3 ...
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    Product Information