Label: KETOTIFEN FUMARATE solution

  • NDC Code(s): 76385-106-17
  • Packager: Bayshore Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 15, 2021

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  • 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 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 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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
  • Inactive ingredients

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

  • Questions?

    Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

    Code No.: GO/DRUGS/557

    Manufactured For:
    Bayshore Pharmaceuticals
    LLC., Short Hills, NJ 07078
    Made in India.

  • Principal Display Panel - Bottle Label

    NDC 76385-106-17

    Ketotifen Fumarate Opthalmic Solution 0.035%

    ANTIHISTAMINE EYE DROPS

    5 mL (0.17 FL OZ)

    Sterile

    ketotifenfumaratelabel

  • Principal Display Panel - Bottle Carton

    NDC 76385-106-17

    Now OTC

    Ketotifen Fumarate Opthalmic Solution 0.035%

    ANTIHISTAMINE EYE DROPS

    UP TO 12 HOURS

    Eye Itch Relief

    Works in Minutes

    Original Prescription Strength

    for ages 3 years and older

    20 day supply

    5 mL (0.17 FL OZ)

    Sterile

    ketotifenfumaratecarton

  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76385-106
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76385-106-171 in 1 CARTON10/15/2021
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20405910/15/2021
    Labeler - Bayshore Pharmaceuticals, LLC (968737416)
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