Label: KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/14

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

  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to ketotifen fumarate 0.035%)

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  • Purpose

    Antihistamine

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  • Uses

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

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  • Warnings

    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 eye s
    itching 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.

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  • 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.
    Children under 3 years of age: consult a doctor
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  • Other information

    Store at 4-25°C (39-77°F)

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  • Inactive ingredients

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

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  • Questions or comments?

    Toll Free Product Information

    Call:1-800-553-5340

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com ©2013 Walgreen Co.

    MADE IN U.S.A.

    ITEM 306487

    9323200

    FU60109

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    VALUE SIZE

    Well at

    Walgreens

    WALGREENS PHARMACIST RECOMMENDED≠

    STERILE

    ORIGINAL

    PRESCRIPTION STRENGTH

    Eye Itch

    Relief

    Ketotifen Fumarate

    Ophthalmic Solution

    Antihistamine Eye Drops

    Works in minutes
    For ages 3 years & older
    60-day supply

    UP TO 12 HOURS

    0.34 FL OZ (10 mL)

    Compare to Zaditor® active ingredient#

    Walgreens Eye Itch Relief Carton 10mL
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  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9060
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    KETOTIFEN FUMARATE (Ketotifen) Ketotifen 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    benzalkonium chloride  
    glycerin  
    hydrochloric acid  
    sodium hydroxide  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9060-00 1 in 1 CARTON
    1 10 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 01/25/2013
    Labeler - Walgreens (008965063)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(0363-9060), ANALYSIS(0363-9060), STERILIZE(0363-9060), PACK(0363-9060), LABEL(0363-9060)
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