Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated October 1, 2024

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

View All Sections
  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumerate 0.035%)

  • Purpose

    Antihistamine

  • Uses

    for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

  • Warnings

    For external use only

    Do not use

    • if you are sensitive to any ingredient in this product
    • if solution changes color or becomes cloudy
    • to treat contact lens related irritation

    When using this product

    • remove contact lenses before use
    • wait at least 10 minutes before re-inserting contact lenses after use
    • do not touch tip of container to any surface to avoid contamination
    • 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 eyes
    • itching that 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 and older:
      • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    • children under 3 years of age:consult a doctor
  • Other information

    store at 4-25 °C (39-77 °F)

  • Inactive ingredients

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

  • Questions or comments?

    [Phone icon] Call: 1-833-354-4500

  • HOW SUPPLIED

    Product: 50090-7253

    NDC: 50090-7253-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • Ketotifen Fumarate

    Label Image
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-7253(NDC:50804-601)
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-7253-01 in 1 CARTON09/24/2024
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199604/01/2024
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-7253)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!