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 January 27, 2022

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 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 (1-800-222-1222) 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?

    Call: 1-800-553-5340

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  • Package/Label Principal Display Panel

    VALUE SIZE

    NDC 0363-0038-10

    Walgreens

    Compare to the active ingredient in
    Zaditor®††

    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)

    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)

    second-carton
  • 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)