Label: KETOTIFEN FUMARATE solution
KETOTIFEN FUMARATE solution/ drops

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

Drug Label Information

Updated May 21, 2021

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  • ACTIVE INGREDIENT

    Ketotifen (0.025%)

    (equivalent to ketotifen fumarate 0.035%)

  • PURPOSE

    Antihistamine

  • WHEN USING

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

  • WARNINGS

    For external use only

    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.

  • INSTRUCTIONS FOR USE

    Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
    Children under 3 years of age: Consult a doctor.

  • QUESTIONS

    Only for use in the eye.
    Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    114212

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-114(NDC:60505-6215)
    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
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-114-055 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07735406/25/2020
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-212(NDC:17478-717)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-212-055 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795805/07/2021
    Labeler - DIRECT RX (079254320)
    Registrant - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320relabel(72189-114, 72189-212)
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