Label: OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride ophthalmic solution

  • NDC Code(s): 72657-168-50
  • Packager: GLENMARK THERAPEUTICS INC., USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 29, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Purpose

    Olopatadine (0.1%).
    (equivalent to olopatadine hydrochloride 0.111%)

    Antihistamine and redness reliever
  • INDICATIONS & USAGE

    Uses

    temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

  • WARNINGS

    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
    •
    do not wear a contact lens if your eye is red
  • STOP USE

    Stop use and ask a doctor if you experience:

    •
    eye pain
    •
    changes in vision
    •
    increased redness of the eye
    •
    itching worsens or lasts for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    adults and children 2 years of age and older:
    •
    put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
    •
    if using other ophthalmic products while using this product, wait at least 5 minutes between each product
    •
    replace cap after each use
    •
    children under 2 years of age: consult a doctor
  • Other information

    •
    only for use in the eye
    •
    store between 4°C to 25°C (39°F to 77°F)
  • Inactive ingredients

    benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid and/ or sodium hydroxide (to adjust PH), sodium chloride and water for injection.

  • Questions or comments?

    In the U.S., call weekdays 9 AM to 6 PM at 1 (888) 721-7115.

    Distributed by:

    Glenmark Therapeutics Inc., USA

    Mahwah, NJ 07430

    Product of Spain

    May 2023

  • PRINCIPAL DISPLAY PANEL

    NDC 72657-168-50

    Olopatadine hydrochloride ophthalmic solution 0.1%

    Antihistamine and Redness Reliever

    Twice Daily Relief
    Eye Allergy Itch & Redness Relief

    5 mL
    STERILE

    carton


    NDC 72657-168-50

    Olopatadine hydrochloride ophthalmic solution 0.1%

    Antihistamine and Redness Reliever

    Twice Daily Relief
    Eye Allergy Itch & Redness Relief



    5 mL
    STERILE

    label
  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride ophthalmic solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-168
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-168-501 in 1 CARTON07/26/2024
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20081007/26/2024
    Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
    Establishment
    NameAddressID/FEIBusiness Operations
    SamChunDang Pharm Co, Ltd687792325MANUFACTURE(72657-168)
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