Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated January 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

  • Purpose

    Antihistamine

  • Uses

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

  • Warnings

    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 the tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lens after use
    • 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 eye
    • itching worsens or lasts 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 of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Inactive ingredients

    Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

  • Questions or comments?

    1-800-932-5676

  • Principal Display Panel Text for Container Label:

    LEADER™ Logo

    NDC 70000-0124-1

    Sterile

    Eye Itch

    Relief

    Ketotifen Fumarate Ophthalmic Solution

    Antihistamine Eye Drops

    5 mL (0.17FL OZ)

    Figure
  • Principal Display Panel Text for Carton Label:

    LEADER™ Logo

    NDC 70000-0124-1

    Sterile

    Eye Itch

    Relief

    Ketotifen Fumarate Ophthalmic Solution

    Antihistamine Eye Drops

    Up to 12 Hours

    of Itch Relief COMPARE TO

    Works in Minutes ZADITOR®

    Original Prescription ANTIHISTAMINE

    Strength EYE DROPS

    Active ingredient*

    For Ages 3 Years

    & Older 100% Money

    30-day Supply Back Guarantee

    5 mL (0.17 FL OZ)

    Figure
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0124
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0124-11 in 1 CARTON01/18/2017
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795801/18/2017
    Labeler - Cardinal Health (063997360)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(70000-0124) , ANALYSIS(70000-0124) , STERILIZE(70000-0124) , PACK(70000-0124) , LABEL(70000-0124)
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