Label: EYE ITCH RELIEF- ketotifen fumarate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 30, 2020

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  • Active ingredient

    Ketotifen 0.025%

  • Purpose

    Antihistamine

    (equivalent to ketotifen fumarate 0.035%)

  • Uses

    For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

  • WarningsFor 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 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 and water for injection.

  • Questions?

    Call: 1-800-553-5340

    *This product is not manufactured or distributed by Novartis, distributor of Zaditor.

  • Package/Label Principal Display Panel – 5mL carton

    NDC 21130-601-05

    Signature™
    Care

    Quality Guaranteed

    STERILE
    ORIGINAL PRESCRIPTON STRENGTH

    Eye Itch Relief
    ketotifen fumarate
    ophthalmic solution 0.035%
    Antihistamine Eye Drops

    Compare to the active ingredient in Zaditor*

    Up to 12 hours


    0.17 FL OZ (5mL)

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-601
    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:21130-601-051 in 1 CARTON08/20/2014
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199608/20/2014
    Labeler - Safeway (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(21130-601)
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