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Ketotifen Fumarate (Akorn, Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (17478-717-10) > 5 mL in 1 BOTTLE, DROPPER Label Information
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (17478-717-11) > 10 mL in 1 BOTTLE, DROPPER Label Information

Complete Ketotifen Fumarate Information

  • 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 tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lenses after use
    • 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 eye
    • itching 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 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 doctor.

  • 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 Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).


  • Questions?

    call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-717-10

    Ketotifen Fumarate

    Ophthalmic Solution

    ANTIHISTAMINE EYE DROPS

    5 mL (0.17 FL OZ) Sterile

    Principal Display Panel Text for Container Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Now OTC! NDC 17478-060-12

    Akorn Logo

    Ketotifen

    Fumarate

    Ophthalmic

    Solution

    ANTIHISTAMINE EYE DROPS

    UP TO 12 HOURS EYE ITCH RELIEF

    Works in Minutes

    Original Prescription Strength

    FOR AGES 3 YEARS AND OLDER

    30 DAY SUPPLY

    5 mL (0.17 FL OZ) Sterile

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17478-717
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-717-10 1 in 1 CARTON 10/01/2007
    1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 10/01/2007
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn AG 482198285 MANUFACTURE(17478-717) , ANALYSIS(17478-717) , PACK(17478-717) , LABEL(17478-717)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 603980319 MANUFACTURE(17478-717) , REPACK(17478-717) , ANALYSIS(17478-717) , LABEL(17478-717) , PACK(17478-717) , RELABEL(17478-717) , STERILIZE(17478-717)