Label: EYE ITCH RELIEF- ketotifen fumarate solution

  • NDC Code(s): 70000-0522-1, 70000-0522-2
  • Packager: Cardinal Health
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 15, 2021

If you are a healthcare professional or from the pharmaceutical industry 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 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
    (1-800-222-1222) 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?

    [phone icon] Toll Free Product Information
    Call: 1-877-758-1480

  • Package/Label Principal Display Panel

    LEADER[heart icon]™

    NDC 70000-0522-2

    Sterile Eye Drops

    Eye Itch
    Relief
    ketotifen fumarate
    ophthalmic solution 0.035%
    ANTIHISTAMINE EYE DROPS

    Up to 12 Hours

    Works in Minutes

    Original Prescription Strength

    For Ages 3 Years and Older

    COMPARE TO
    ZADITOR®
    active ingredient

    100% Money
    Back Guarantee

    0.34 FL OZ (10 mL)

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0522
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0522-11 in 1 CARTON08/07/2020
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70000-0522-21 in 1 CARTON08/07/2020
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199608/07/2020
    Labeler - Cardinal Health (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(70000-0522) , PACK(70000-0522) , LABEL(70000-0522)