Label: ALAWAY- ketotifen fumarate solution/ drops

  • NDC Code(s): 24208-601-05, 24208-601-10, 24208-601-90, 24208-601-95
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 3, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumerate 0.035%)

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  • Purpose

    Antihistamine

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  • Uses

    For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

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  • 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 doctor if you experience any of the following:

    eye pain
    changes in vision
    redness of the eyes
    itching that worsens or lasts more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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

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  • Other Information

    Store at 4-25°C (39-77°F)

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  • Inactive ingredients

    benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

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  • Questions or comments?

    Toll Free Product Information

    Call: 1-800-553-5340

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  • Package/Label Principal Display Panel

    Alaway 10mL Carton

    60 DAY SUPPLY
    NDC 24208-601-10

    BAUSCH + LOMB

    Alaway®

    ketotifen fumarate ophthalmic solution 0.035%

    ANTIHISTAMINE EYE DROPS

    UP TO

    12

    HOURS

    EYE ITCH RELIEF

    WORKS IN MINUTES!

    Original Prescription Strength
    For ages 3 years and older

    STERILE 0.34 FL OZ (10 mL)

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  • INGREDIENTS AND APPEARANCE
    ALAWAY 
    ketotifen fumarate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-601
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-601-10 1 in 1 CARTON 12/01/2006
    1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2 NDC:24208-601-95 1 in 1 CARTON 12/01/2006
    2 1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3 NDC:24208-601-05 1 in 1 CARTON 12/01/2006
    3 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4 NDC:24208-601-90 2 in 1 CARTON 12/01/2006
    4 10 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
    NDA NDA021996 12/01/2006
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-601)
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