Label: OLOPATADINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 62332-709-05
  • Packager: Alembic Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 17, 2024

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  • ACTIVE INGREDIENT(S)

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

  • PURPOSE

    Antihistamine and redness reliever

  • USE(S)

    temporarily relieves itchy red 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
    • do not wear a contact lens if your eye is red


  • STOP USE AND ASK 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

    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/sodium hydroxide (adjust pH), sodium chloride, and water for Injection

  • QUESTIONS?

    Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

  • PRINCIPAL DISPLAY PANEL

    Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Gland

    olopatadine-container-gland

     

    Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Alembic 

    olopatadine-container-f3


     Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Gland

    olopatadine-carton-gland

     

    Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Alembic

    olopatadine-carton-f3

     

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62332-709
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62332-709-051 in 1 CARTON02/18/2021
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20991902/18/2021
    Labeler - Alembic Pharmaceuticals Inc. (079288842)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gland Pharma Limited918601238MANUFACTURE(62332-709)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alembic Pharmaceuticals Limited (F3)675480734MANUFACTURE(62332-709)
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