Label: OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 23, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

  • Purpose

    Antihistamine

  • Uses

    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 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.

    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 4° and 25°C (39° and 77°F)
  • Inactive ingredients

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

  • Questions or comments?

    call 1-855-839-8195

  • PRINCIPAL DISPLAY PANEL

    NDC 42571-152-35
    Olopatadine Hydrochloride
    Opthalmic Solution
    USP, 0.2%
    2.5 mL
    Antihistamine
    Once Daily relif
    Micro Labs


    container label


    NDC 42571-152-35
    Olopatadine Hydrochloride
    Opthalmic Solution
    USP, 0.2%
    2.5 mL
    Antihistamine
    works in minutes
    Once Daily relif
    Micro Labs


    carton label
  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE  
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42571-152
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (colorless to nearly colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42571-152-351 in 1 CARTON12/16/2020
    12.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20462012/16/2020
    Labeler - Micro Labs Limited (862174955)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micro Labs Limited677600482analysis(42571-152) , label(42571-152) , manufacture(42571-152) , pack(42571-152)