Label: EYE ITCH RELIEF- ketotifen fumarate solution 

  • 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 04/13

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

    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. (1-800-222-1222)

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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 8-12 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 20-25°C (68-77°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?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to the active ingredient in Zaditor®

    EYE ITCH RELIEF

    KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

    ANTIHISTAMINE EYE DROPS

    Original prescription strength

    For ages 3 yrs. and older

    30 day supply

    GET UP TO 12 HOURS OF RELIEF

    Sterile

    Eye Itch Relief Carton Image
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  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-982
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN 0.25 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    WATER  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-982-01 1 in 1 CARTON
    1 5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 09/14/2010
    Labeler - CVS Pharmacy (062312574)
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