Label: KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 

  • Label RSS
  • 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to ketotifen fumarate 0.035%)

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  • Purpose

    Antihistamine

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  • Uses

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

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  • 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 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 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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.
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  • Other information

    • only for use in the eye
    • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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  • Inactive ingredients

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

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  • Questions or Comments?

    1-800-932-5676

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Well at

    Walgreens NDC 0363-9060-00

    STERILE ● ORIGINAL

    PRESCRIPTION STRENGTH

    Eye Itch Relief

    Ketotifen Fumarate

    Ophthalmic Solution

    Antihistamine Eye Drops 0.34 FL OZ (10 mL)

    Principal Display Panel Text for Container Label:
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Well at

    Walgreens NDC 0363-9060-00

    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

    12

    HOUR

    0.34 FL OZ (10 mL)

    Compare to Alaway® active ingredient#

    Principal Display Panel Text for Carton Label
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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 0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    benzalkonium chloride  
    glycerin  
    water  
    hydrochloric acid  
    sodium hydroxide  
    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; Combination Product Type = C112160
    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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