Label: KETOTIFEN FUMARATE solution/ drops

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

Drug Label Information

Updated May 11, 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 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

  • HOW SUPPLIED

    Product: 50090-6472

    NDC: 50090-6472-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • KETOTIFEN FUMARATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6472(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:50090-6472-01 in 1 CARTON05/10/2023
    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 - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6472)
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