Label: ALLERGY EYE DROPS- ketotifen fumarate solution/ drops

  • NDC Code(s): 58790-301-02
  • Packager: Advanced Vision Research (Subsidiary of Akorn, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 13, 2013

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. (1-800-222-1222)

  • 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°-25°C (68°-77°F) [see USP Controlled Room Temperature]
  • Inactive ingredients

    benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

  • Questions or comments?

    1-800-579-8327

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    CVS

    pharmacy®

    NDC 58790-301-02

    ALLERGY

    EYE DROPS

    KETOTIFEN FUMARATE

    OPHTHALMIC SOLUTION

    ANTIHISTAMINE

    EYE DROPS

    10 mL (0.34 FL OZ) STERILE

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    CVS

    pharmacy®

    NDC 58790-301-02

    Compare to the

    active ingredient

    in Alaway®*

    NEW!

    Contains the drug

    Ketotifen Fumarate

    ALLERGY

    EYE DROPS

    KETOTIFEN FUMARATE

    OPHTHALMIC SOLUTION

    ANTIHISTAMINE

    EYE DROPS

    Works in minutes

    • Original prescription strength
    • For ages 3 years & older
    • Relief for itchy eyes
    • 60-day supply

    up to

    12

    HOURS

    10 mL ITCH RELIEF

    (0.34 FL OZ)

    STERILE

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ALLERGY EYE DROPS 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-301
    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:58790-301-021 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795811/14/2013
    Labeler - Advanced Vision Research (Subsidiary of Akorn, Inc.) (969124536)
    Registrant - Akorn, Inc. (062649876)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc603980319MANUFACTURE(58790-301) , ANALYSIS(58790-301) , STERILIZE(58790-301) , PACK(58790-301) , LABEL(58790-301)