Label: EYE ITCH RELIEF- ketotifen fumarate solution/ drops

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

Drug Label Information

Updated February 10, 2022

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

View All Sections
  • 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

    For external use only

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

  • Questions or comments?

    1-800-932-5676

    Serious side effects associated with use of this product may be reported to this number

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    CVS Health™ Logo

    Eye Itch Relief

    KETOTIFEN FUMARATE

    OPHTHALMIC SOLUTION

    0.035%

    Antihistamine eye drops

    STERILE

    5 mL (0.17 FL OZ)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    CVS Health™ Logo Compare to the active

    ingredient in Zaditor®*

    NDC 59779-705-01

    Eye Itch

    Relief

    KETOTIFEN FUMARATE

    OPHTHALMIC SOLUTION 0.035%

    Antihistamine eye drops

    • Works in minutes

    • Original prescription strength

    • For ages 3 and older

    • 30 day supply

    GET UP TO

    12

    HOURS

    OF RELIEF

    Actual Product

    Size on Side Panel

    STERILE

    5 mL (0.17 FL OZ)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    EYE ITCH RELIEF 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-705
    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:59779-705-011 in 1 CARTON02/07/2014
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795802/07/2014
    Labeler - CVS Pharmacy (062312574)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(59779-705) , ANALYSIS(59779-705) , STERILIZE(59779-705) , PACK(59779-705) , LABEL(59779-705)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, AG482198285MANUFACTURE(59779-705)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696873LABEL(59779-705) , PACK(59779-705)
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!