Label: KETOTIFEN FUMARATE solution

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

Drug Label Information

Updated June 1, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to ketotifen fumarate 0.035%)

  • Purpose

    Antihistamine

  • Use

    Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

  • Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
    • to treat contact lens related irritation

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lenses after use
    • 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 eye
    • itching 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 of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
    • Children under 3 years of age: Consult a doctor.
  • Other information

    • Only for use in the eye.
    • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
  • Inactive ingredients

    benzalkonium chloride 0.01%, glycerol, hydrochloric acid and/or sodium hydroxide, and water for injection

  • Questions or comments?

    Call toll-free 1-800-706-5575

    Weekdays 8:30 AM - 5:00 PM Eastern Standard Time

  • Principal Display Panel - Bottle Label

    Rugby Laboratories

    NDC 0536-1222-40

    Eye Itch Relief

    Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

    ketotifenfumaratelabel

  • Principal Display Panel - Bottle Carton

    Rugby Laboratories

    NDC 0536-1222-40

    Eye Itch Relief

    Ketotifen Fumarate Opthalmic Solution 0.025% 5 ml bottle

    ketotifenfumaratecarton

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1222
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1222-401 in 1 CARTON04/24/2019
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735404/24/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - Apotex Inc (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc255092496analysis(0536-1222) , manufacture(0536-1222)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sifavitor SPA437723684api manufacture(0536-1222)