Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated May 23, 2022

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

  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumarate 0.035%)

  • Purpose

    Antihistamine

  • Uses

    for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

  • Warnings

    For external use only

    Do not use

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

    When using this product

    remove contact lenses before use
    wait at least 10 minutes before re-inserting contact lenses after use
    do not touch tip of container to any surface to avoid contamination
    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 eyes
    itching that 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 and older:
    put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
    if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    children under 3 years of age: consult a doctor

    Other information

    store at 4-25°C (39-77°F)

  • Inactive ingredients

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

    Questions or comments?

    [phone icon]Call: 1-800-632-6900

    DISTRIBUTED BY
    THE KROGER CO., CINCINNATI, OHIO 45202
    PRODUCT OF ITALY

    *Systane® and Zaditor® are registered
    trademarks of Alcon, Inc., Fribourg,
    Switzerland CH-1701. Alcon, Inc. is not
    affiliated with The Kroger Co. or this product.

    QUALITY GUARANTEE
    800-632-6900
    www.kroger.com

  • Package/Label Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-398
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-398-051 in 1 CARTON06/01/2022
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199606/01/2022
    Labeler - Kroger Company (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(30142-398)