Label: LEADER EYE ITCH RELIEF DROPS- ketotifen fumarate solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 21, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                             Purpose

    Ketotifen (0.025%)..........................................Antihistamine

    (Equivalent to ketotifen fumarate 0.035%)

  • PURPOSE

    Use

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

  • DO NOT USE

    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


    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

    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

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

    • Only for use in the eye
    • Store between 20o-25oC (68o to 77oF) (See USP controlled Room Temperature)
    • Do not use if cap seal ring is broken
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    LEADER EYE ITCH RELIEF DROPS 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1163
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN FUMARATE0.345 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-1163-71 in 1 CARTON
    15 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/21/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
    Registrant - UNITED EXCHANGE CORP. (840130579)
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