Label: KETOTIFEN FUMARATE solution

  • NDC Code(s): 58790-008-05, 58790-008-10
  • Packager: Advanced Vision Research (Subsidiary of Akorn, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 4, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to Ketotifen Fumarate 0.035%)

  • Purpose

    Antihistamine

  • Uses

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

  • 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 this product

    • do not touch tip of container to any surfaces 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.

  • 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.
  • Other information

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

    Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

  • Questions?

    call toll-free 1-800-579-8327, weekdays, 7:00 AM-5:30 PM EST

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Thera Tears logo NDC 58790-008-05
    Ketotifen Fumarate
    Ophthalmic Solution
    ANTIHISTAMINE EYE DROPS
    Sterile                EYE ITCH
    5mL (0.17 FL OZ)      RELIEF

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Thera Tears logo
    Ketotifen Fumarate
    Ophthalmic Solution
    Antihistamine Eye Drops STERILE
    EYE ITCH
    RELIEF
    Up to
    12
    Hours

    • Works in Minutes
    • Original Prescription
      Strength
    • For Ages 3 Years and Older
    • 30 Day Supply

                          ADVANCED
                          VISION RESEARCH logo
    0.17 FL OZ (5 mL)     AN AKORN COMPANY

    Principal Display Panel Text for Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Thera Tears logo NDC 58790-008-10

    Ketotifen Fumarate

    Ophthalmic Solution

    ANTIHISTAMINE EYE DROPS

    Sterile ALLERGY

    EYE ITCH

    0.34 FL OZ (10 mL) RELIEF

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    100% More Free*

    *10 ml for the

    price of

    5 ml

    Thera Tears logo

    Ketotifen Fumarate

    Ophthalmic Solution

    Antihistamine Eye Drops STERILE

    ALLERGY

    EYE ITCH

    RELIEF

    Up to

    12

    Hours

    • Works in Minutes
    • Original Prescription
      Strength
    • For Ages 3 Years and Older
    • 60 Day Supply

    ADVANCED

    VISION RESEARCH logo

    0.34 FL OZ (10 mL) AN AKORN COMPANY

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-008
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen Fumarate0.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58790-008-051 in 1 CARTON
    15 mL in 1 BOTTLE, DROPPER
    2NDC:58790-008-101 in 1 CARTON
    210 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795803/15/2012
    Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc603980319MANUFACTURE(58790-008) , ANALYSIS(58790-008) , STERILIZE(58790-008) , PACK(58790-008) , LABEL(58790-008)