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 April 1, 2024

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  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumerate 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: 1-833-354-4500

  • Package/Label Principal Display Panel

    5ml carton

    GOODSENSE®NDC 50804-601-05

    For ages 3 years and older

    Eye Itch Relief

    ketotifen fumarate
    ophthalmic solution 0.035%

    ANTIHISTAMINE EYE DROPS

    Up to 12hours
    works in minutes
    Original Prescription Strength

    Compare to active ingredient of

    Systane ZADITOR*

    STERILE 0.17 FL OZ (5 ml)

    9797500

    MH60107

  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-601
    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:50804-601-051 in 1 CARTON04/01/2024
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199604/01/2024
    Labeler - PERRIGO DIRECT INC. (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625manufacture(50804-601)
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