Label: KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- ketotifen fumarate solution/ drops

  • NDC Code(s): 72485-617-10
  • Packager: Armas Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 1, 2024

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active ingredient
    Ketotifen (0.025%) (equivalent to Ketotifen Fumarate 0.035%)
  • Purpose
    Antihistamine
  • Use
    Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
  • Warnings
    Do not use - if solution changes color or becomes cloudy - if you are sensitive to any ingredient in this product - to treat contact lens related irritation - When using this product - do not touch ...
  • Directions
    Adults and children 3 years of age 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 ...
  • Other information
    Only for use in the eye. Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
  • Inactive ingredients
    Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
  • Questions?
    call toll-free - 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT
  • SPL UNCLASSIFIED SECTION
    Now OTC! ANTIHISTAMINE EYE DROPS - UPTO 12 HOURS EYE ITCH RELIEF - • Works in Minutes - • Original Prescription Strength - FOR AGES 3 YEARS AND OLDER - 30 DAY SUPPLY - Sterile - Original ...
  • Packaging
    Ketolbl3
  • INGREDIENTS AND APPEARANCE
    Product Information