Label: EYE ITCH RELIEF- ketotifen fumarate solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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
    if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    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?

    {Phone icon} Call: 1-800-459-7043

    *This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.

  • Package/Label Principal Display Panel – 5mL carton

    Compare to

    Systane ZADITOR

    active ingredient*

    NDC 21130-601-05

    Signature
    SELECT®

    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


    STERILE 0.17 FL OZ (5 mL)

    20074700

    GI60107

    carton
  • 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)