Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated September 23, 2014

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  • Active ingredient

    Ketotifen (0.025%)

  • Purpose

    Antihistamine

    (equivalent to ketotifen fumarate 0.035%)

  • Uses

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

  • 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 eyes
    •
    itching that 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.

  • 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
  • Other information

    •
    store at 4-25°C (39-77°F)
  • Inactive ingredients

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

  • QUESTIONS

    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 306486

    9323100

    FU60107

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

    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
    •
    30-day supply

    0.17 FL OZ (5 mL)

    12 UP TO 12 HOURS

    Compare to Zaditor® active ingredient‡‡

    Eye Itch Relief
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0610
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0610-102 in 1 CARTON
    15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795805/01/2012
    Labeler - Walgreens (008965063)
    Registrant - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc603980319MANUFACTURE(0363-0610) , ANALYSIS(0363-0610) , STERILIZE(0363-0610) , PACK(0363-0610) , LABEL(0363-0610)
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