Label: GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF- ketotifen fumarate solution

  • 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 07/13

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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  • Use

    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 cloudyi

    . If you are sensitive to any ingredient in this product

    . To treat contact lens related irritation

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  • 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

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  • 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

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  • 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

    NDC 68258-8900-05

    NDC 68258-8900-05

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  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68258-8900(NDC:24385-494)
    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
    GLYCERIN  
    WATER  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68258-8900-5 5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077958 11/13/2010
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 relabel(68258-8900), repack(68258-8900)
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