Label: KETOTIFEN FUMARATE solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 16, 2020

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

  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumerate 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 doctor if you experience any of the following:

    eye pain
    changes in vision
    redness of the eyes
    itching that worsens or lasts 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?

    Toll Free Product Information
    Call: 1-800-645-2158

    Distributed by:
    RUGBY® LABORATORIES
    17177 N Laurel Park Drive
    Suite 233, Livonia, MI 48152
    www.rugbylaboratories.com
    Product of Italy

  • Package/Label Principal Display Panel

    carton5ml


    NDC 0536-1252-40

    Rugby®

    Compare to the
    active ingredient
    in Zaditor*

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

    UP TO
    12
    HOURS
    EYE ITCH RELIEF

    Works in Minutes
    Original Prescription
    Strength
    For Ages 3 Years
    and Older

                                         5mL
    STERILE      (0.17 FL OZ)

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1252
    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:0536-1252-401 in 1 CARTON09/18/2020
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02199609/18/2020
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(0536-1252) , PACK(0536-1252) , LABEL(0536-1252)