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 December 15, 2023

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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)

    Systane®
    ZADITOR®

    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
    Country of Origin: Italy

    300048650-0821

    ACTUAL SIZE

    LOT:          EXP.:

    Zaditor Carton

    Systane®
     ZADITOR®
     ketotifen fumarate ophthalmic solution 0.035%

    ANTIHISTAMINE EYE DROPS
    EYE ITCH RELIEF
    5mL (0.17 FL OZ) STERILE

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

    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.

    Manufactured by:
    Alcon Laboratories, Inc.
    6201 South Freeway,
    Fort Worth, TX 76134

    H15433-1018

    bottle label
  • 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 CARTON03/13/2013
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-4011-062 in 1 CARTON01/08/2013
    25 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-4011-113 in 1 CARTON02/13/2015
    35 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07720001/08/2013
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Research LLC (007672236)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-4011)
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