Label: KETOTIFEN FUMARATE solution/ drops

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

Drug Label Information

Updated December 8, 2023

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  • 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 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 or comments?

    [phone icon]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

    9690002

    AK60107

  • Package/Label Principal Display Panel

    carton


    NDC 0536-1252-40

    Rugby®

    Compare to
    Systane ZADITOR

    active ingredient*

    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)
  • 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)
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