Label: ALAWAY PRESERVATIVE FREE- ketotifen fumarate solution/ drops

  • NDC Code(s): 24208-600-01, 24208-600-99
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 4, 2022

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  • Active ingredient

    Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

  • Purpose

    Antihistamine

  • Uses

    Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

  • Warnings

    For external use only

    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
    •
    discard unused portion immediately after use
    •
    remove contact lenses before use
    •
    does not include a preservative.

    Stop use and ask a doctor if you experience any of the following:

    •
    eye pain
    •
    changes in vision
    •
    redness of the eyes
    •
    itching that 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:
    •
    twist tab completely off to open
    •
    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 between 4-25 °C (39-77 °F).
    •
    Use only if foil pouch is sealed and single-dose vial is intact.
    •
    Store unused units in foil pouch.
    •
    Protect from light.
  • Inactive ingredients

    glycerin, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection

  • Questions or comments?

    [phone icon]Call Toll Free: 1-800-553-5340


    Serious side effects associated with use of this product may be reported to this number.

    Distributed by:

    Bausch & Lomb Americas Inc.

    Bridgewater, NJ 08807 USA

    Product of Italy

    Alaway is a trademark of Bausch & Lomb

    Incorporated or its affiliates.

    © 2022 Bausch & Lomb Incorporated or its affiliates

    9677202

    622243

  • Package/Label Principal Display Panel

    BAUSCH + LOMB

    NDC 24208-600-01

    Alaway®
    Preservative Free

    Ketotifen Fumarate Ophthalmic Solution 0.035%
    ANTIHISTAMINE EYE DROPS

    Eye Itch Relief

    UP TO 12HOURS

    Works in Minutes

    Original Prescription Strength

    For Ages 3 Years And Older

    10 DAY SUPPLY

    20 [4 pouches x five 0.4 mL] SINGLE-DOSE VIALS
    Discard unused portion

    STERILE

    9677202

    622243

    carton
  • INGREDIENTS AND APPEARANCE
    ALAWAY PRESERVATIVE FREE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-600
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-600-014 in 1 CARTON09/24/2020
    15 in 1 POUCH
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:24208-600-9912 in 1 CARTON09/24/2020
    21 in 1 POUCH
    20.4 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20815809/24/2020
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excelvision274234566MANUFACTURE(24208-600)
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