Label: ALAWAY PRESERVATIVE FREE- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated August 19, 2020

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

    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

    9677200

    622243

  • Package/Label Principal Display Panel

    NEW
    PRODUCT

    BAUSCH + LOMB

    NDC 24208-600-01

    Alaway®
    Preservative Free

    Ketotifen Fumarate Ophthalmic Solution 0.035%
    ANTIHISTAMINE EYE DROPS

    Eye Itch Relief

    UP TO
    12
    HOURS

    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

    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
    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)