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

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

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 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 (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    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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