Label: KETOTIFEN FUMARATE OPHTHALMIC SOLUTION- ketotifen fumarate solution/ drops

  • NDC Code(s): 72485-617-10
  • Packager: Armas Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 1, 2024

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

  • 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 Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

  • Questions?

    call toll-free 1-855-473-6847,weekdays, 7:00 AM - 5:30 PM CT

  • SPL UNCLASSIFIED SECTION

    Now OTC!

    ANTIHISTAMINE EYE DROPS

    UPTO 12 HOURS EYE ITCH RELIEF

    Works in Minutes

    Original Prescription Strength

    FOR AGES 3 YEARS AND OLDER
    30 DAY SUPPLY

    Sterile

    Original Prescription Strength

    Do not use if seal on bottle is missing or broken.

    FOR TOPICAL OPHTHALMIC USE ONLY.

    PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

    Distributed by: Armas Pharmaceuticals, Inc.
    Freehold, NJ 07728 (USA)

    Manufactured by: Ophtapharm AG, Riethofstrasse 1,
    Hettlingen, 8442, Switzerland (CHE) for Sentiss

    Made in Switzerland

  • Packaging

    Ketolbl3

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE OPHTHALMIC SOLUTION 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72485-617
    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)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72485-617-101 in 1 CARTON10/09/2023
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795810/09/2023
    Labeler - Armas Pharmaceuticals Inc. (098405973)
    Registrant - SENTISS AG (486920486)