Label: EYE ITCH RELIEF- ketotifen fumarate solution

  • NDC Code(s): 0363-0038-05, 0363-0038-10
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 25, 2026

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

  • Active ingredient

    Ketotifen 0.025%
    (equivalent to ketotifen fumarate 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 content 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 ifyou 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: 1-800-459-6906

  • Package/Label Principal Display Panel

    VALUE SIZE

    NDC 0363-0038-10

    Walgreens

    Compare to Systane® ZADITOR®

    active ingredient ††

    Eye Itch
    Relief

    ketotifen fumarate
    ophthalmic solution 0.035%
    ANTIHISTAMINE EYE DROPS

    Up to 12 Hours

    • Original prescription strength
    • Works in minutes
    • 60 day supply
    • For ages 3

    years and older

    STERILE 0.34 FL OZ (10 mL)

    9756202

    FU60109A

    REV - 0525

    Distributed by: WALGREEN CO., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED walgreens.com
    © 2025 Walgreen Co. PRODUCT OF ITALY. PACKAGED IN THE USA.

    carton

  • Package/Label Principal Display Panel

    VALUE SIZE

    NDC 0363-0038-10

    Walgreens
    Compare to the active
    ingredient in Alaway ®††

    Eye Itch
    Relief
    ketotifen fumarate
    ophthalmic solution 0.035%
    ANTIHISTAMINE EYE DROPS

    Up to 12 Hours

    • Original prescription strength
    • Works in minutes
    • 60 day supply
    • For ages 3 years
      and older

    STERILE 0.34 FL OZ (10 mL)

    9765901

    Distributed by: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED walgreens.com
    © 2023 Walgreen Co. PRODUCT OF ITALY

    Carton 10 mL Blue
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0038
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0038-051 in 1 CARTON09/03/2013
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0038-101 in 1 CARTON09/03/2013
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199609/03/2013
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625manufacture(0363-0038)