Label: KETOTIFEN FUMARATE solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 1, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ketotifen (0.025%)

    (equivalent to Ketotifen Fumarate 0.035%)

  • Purpose

    Antihistamine

  • Use

    Temporarily 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 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.

  • 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° 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 Add and/or Sodium Hydroxide (to adjust pH).

  • Questions?

    call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Now OTC! NDC 71205-115-05

    Ketotifen

    Fumarate

    Ophthalmic

    Solution

    ANTIHISTAMINE EYE DROPS

    UP TO 12 HOURS EYE ITCH RELIEF

    Works in Minutes

    Original Prescription Strength

    FOR AGES 3 YEARS AND OLDER

    30 DAY SUPPLY

    5 mL (0.17 FL OZ) Sterile

    71205-115-05
  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-115(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
    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:71205-115-051 in 1 CARTON09/04/2018
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795810/01/2007
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-115)
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