Label: ALAWAY- ketotifen fumarate kit

  • NDC Code(s): 24208-901-99
  • 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 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 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.

  • 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

  • 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?

    Toll Free Product Information Call: 1-800-553-5340

  • Package/Label Principal Display Panel

    Alaway Bonus Pack Carton

    NDC 24208-901-99

    BONUS 1ML TRAVEL SIZE

    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

    [image – 1 mL Bottle]

    [image – 10 mL Bottle]

    STERILE 0.34 FL OZ (10 mL)+

    0.03 FL OZ (1 mL)

  • INGREDIENTS AND APPEARANCE
    ALAWAY 
    ketotifen fumarate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-901
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-901-991 in 1 CARTON; Type 0: Not a Combination Product12/01/2006
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, DROPPER 1 mL
    Part 20 BOTTLE, DROPPER 1 mL
    Part 1 of 2
    ALAWAY 
    ketotifen fumarate solution
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199612/01/2006
    Part 2 of 2
    ALAWAY 
    ketotifen fumarate solution
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199612/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199612/01/2006
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(24208-901)