Label: ZADITOR- ketotifen fumarate solution

  • NDC Code(s): 0065-4011-05, 0065-4011-06, 0065-4011-11
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 16, 2020

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  • ACTIVE INGREDIENT

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

    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

    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

    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 8-12 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 ingredients

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

  • Questions?

    In the US, call toll-free 1-800-757-9195

    alcon.medinfo@alcon.com
    www.systane.com

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Systane®
    ZADITOR®
    ketotifen fumarate ophthalmic solution 0.035%
     
    ANTIHISTAMINE EYE DROPS
    EYE ITCH RELIEF
     
    ●   Works in minutes
    ●   Original prescription strength
    ●   For ages 3 years and older

    up to 12 HOURS

    Alcon
    STERILE
    30 DAY SUPPLY
    5mL (0.17 FL OZ)

    Original Prescription Strength
    Up to 12 Hour Itch Relief
    Works in Minutes
    For Ages 3 Years and Older
    30 DAY SUPPLY

    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.
    Fort Worth, TX 76134 USA
    a Novartis Division
    Country of Origin: Italy

    9016645-0918

    ACTUAL SIZE

    LOT:          EXP.:

    Carton2
  • INGREDIENTS AND APPEARANCE
    ZADITOR  
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-4011
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen.25 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:0065-4011-051 in 1 CARTON12/21/2012
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-4011-062 in 1 CARTON12/21/2012
    25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-4011-113 in 1 CARTON12/21/2012
    35 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 - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Research LLC (007672236)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-4011)
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