Label: ZADITOR- ketotifen fumarate solution

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

Drug Label Information

Updated November 9, 2017

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  • OTC - ACTIVE INGREDIENT SECTION

    Ketotifen (0.025%)
    (equivalent to ketotifen fumarate 0.035%)

  • OTC - PURPOSE SECTION

    Antihistamine

  • INDICATIONS & USAGE SECTION

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

  • WARNINGS SECTION

    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
  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION SECTION

    • Adults and children 3 years of age 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

    • Only for use in the eye.
    • Store between 4°-25°C (39°-77°F).
  • INACTIVE INGREDIENT SECTION

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

  • HOW SUPPLIED

    Product: 50090-1037

    NDC: 50090-1037-0 5 mL in a BOTTLE, DROPPER

  • QUESTIONS?

    call toll-free
    1-800-757-9195
    MedInfo@AlconLabs.com
    www.zaditor.com
    Serious side effects associated with use of this product may be reported to this number.

  • ketotifen fumarate

    Label Image
  • INGREDIENTS AND APPEARANCE
    ZADITOR  
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1037(NDC:0065-4011)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1037-01 in 1 CARTON11/28/2014
    15 mL in 1 BOTTLE, DROPPER ; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07720012/21/2012
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1037)
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