Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

  • NDC Code(s): 70000-0124-1
  • Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 12, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    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 the tip of container to any surface to avoid contamination
    ▪
    remove contact lenses before use
    ▪
    wait at least 10 minutes before reinserting contact lens 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 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 to 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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

  • Questions or comments?

    1-800-932-5676

  • .

    *This product is not manufactured or distributed by Alcon Laboratories, distributor of Zaditor®.

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

    Essential to Care™ since 1979

    100% Money Back Guarantee

    Return to place of purchase.

    2080

    CIN 5266457 REV. 11/16

    LKAAL Rev. 08/16

    CIN 5266457 REV. 11/16

    LKAAC Rev. 08/16
  • Principal Display Panel Text for Container Label:

    LEADER™

    NDC 70000-0124-1

    Sterile

    Eye Itch

    Relief

    Ketotifen Fumarate Ophthalmic Solution

    Antihistamine Eye Drops

    5 mL (0.17FL OZ)

    Figure
  • Principal Display Panel Text for Carton Label:

    LEADER™

    NDC 70000-0124-1

    Sterile

    Eye Itch

    Relief

    Ketotifen Fumarate Ophthalmic Solution

    Antihistamine Eye Drops

    Up to 12 Hours

    of Itch Relief

    Works in Minutes

    Original Prescription Strength

    For Ages 3 Years & Older

    30-day Supply

    COMPARE TO ZADITOR® ANTIHISTAMINE EYE DROPS Active ingredient*

    100% Money Back Guarantee

    5 mL (0.17 FL OZ)

    Figure
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0124
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0124-11 in 1 CARTON01/18/201703/31/2028
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795801/18/201703/31/2028
    Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
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