Label: OLOPATADINE HYDROCHLORIDE solution/ drops

  • NDC Code(s): 46708-710-03
  • Packager: Alembic Pharmaceuticals Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 9, 2024

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  • ACTIVE INGREDIENT(S)

    Olopatadine 0.2%................ (equivalent to olopatadine hydrochloride 0.222%)


  • PURPOSE

    Antihistamine

  • USE(S)

    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
    • 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) once daily, no more than once 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 2°C to 25°C (36°F to 77°F)

  • INACTIVE INGREDIENT SECTION

    benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride, and water for Injection.

  • QUESTIONS?

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

  • PRINCIPAL DISPLAY PANEL

    Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Bottle Label - ALEMBIC 

    olopatadine-bottle-alembic

     

    Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2% - Carton Label - ALEMBIC

    olopatadine-carton-alembic

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46708-710
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46708-710-031 in 1 CARTON01/25/2021
    12.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20942001/25/2021
    Labeler - Alembic Pharmaceuticals Limited (650574663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alembic Pharmaceuticals Limited (F3)675480734MANUFACTURE(46708-710)
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