ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]

ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]
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NDC 0065-4011-05, 0065-4011-06
Set ID ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA077200
  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Ketotifen (0.025%)
    (equivalent to ketotifen fumarate 0.035%)
    Antihistamine
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  • INDICATIONS & USAGE

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

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  • 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
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  • 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
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  • STOP 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
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 
    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • 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
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  • Other information

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

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

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  • Questions?

    call toll-free
    1-800-757-9195
    MedInfo@Alcon.com
    www.zaditor.com

    Serious side effects associated with use of this product may be reported to this number.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    New Look   SAME FORMULA

    Systane
    ®
    ZADITOR

    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

    5 mL (0.17 FL OZ)

    STERILE

    30 DAY SUPPLY

    Alcon®

    TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, TX 76134 USA
    © 2009, 2012, 2016 Novartis

    9013176-0416

    ACTUAL SIZE

    LOT:          EXP.:

    Carton
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  • INGREDIENTS AND APPEARANCE
    ZADITOR  
    ketotifen fumarate solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-4011
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen .25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-4011-05 1 in 1 CARTON 12/21/2012
    1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2 NDC:0065-4011-06 2 in 1 CARTON 12/21/2012
    2 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077200 12/21/2012
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Research Ltd (007672236)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Research Ltd 007672236 manufacture(0065-4011)
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