Label: EQUATE EYE ITCH RELIEF- ketotifen fumarate solution

  • NDC Code(s): 49035-231-10, 49035-231-11
  • Packager: Wal-Mart Stores, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 23, 2021

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  • 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 contact 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 or 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

    Store at 4-25°C (39-77°F)

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    NDC 49035-231-11

    equate™

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

    •
    Works in minutes
    •
    Original prescription strength
    •
    For ages 3 years and older
    •
    STERILE

    UP TO 12 HOURS

    2 x 10 mL BOTTLES
    (0.34 FL OZ EACH)

    carton
  • INGREDIENTS AND APPEARANCE
    EQUATE EYE ITCH RELIEF 
    ketotifen fumarate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-231
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 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:49035-231-101 in 1 CARTON01/01/2016
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49035-231-112 in 1 CARTON07/02/2018
    210 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02199601/01/2016
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(49035-231) , PACK(49035-231) , LABEL(49035-231)
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