Label: OLOPATADINE HYDROCHLORIDE solution

  • NDC Code(s): 72476-852-64
  • Packager: Retail Business Services, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 2021

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  • Drug Facts

    Active ingredient
    Olopatadine (0.1%).
    (equivalent to olopatadine hydrochloride, USP 0.111%)

  • Purpose

    Antihistamine and Redness Reliever

  • Uses

    temporarily relieves itchy and 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 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 (1-800-222-1222) 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° to 25°C (39° 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?

    ✆1-855-274-4122

    Distributed by:
    FOODHOLD U.S.A., LLC,
    LANDOVER, MD 20785
    MADE IN INDIA

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

    CAREOne                 NDC 72476-852-64
    EYE ALLERGY ITCH
    & REDNESS RELIEF
    Olopatadine Hydrochloride
    Ophthalmic Solution USP, 0.1%
    Antihistamine and Redness Reliever
    STERILE            5 mL (0.17 FL OZ)
    olopatadine-figure-1

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

    CAREOne          NDC 72476-852-64
    Compare to the Active Ingredient in
    Pataday® Twice Daily Relief®
    EYE ALLERGY ITCH
    & REDNESS RELIEF
    Olopatadine Hydrochloride
    Ophthalmic Solution USP, 0.1%
    TWICE DAILY
    Now available without a prescription
    Antihistamine and Redness Reliver
    Works in Minutes
    Relief from Allergens:
    Pet Dander, Pollen, Grass, Ragweed
                                              STERILE
                                              5 mL (0.17 FL OZ)
    olopatadine-figure-2

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-852
    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, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-852-641 in 1 CARTON05/06/2021
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20481205/06/2021
    Labeler - Retail Business Services, LLC. (967989935)
    Registrant - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650498244ANALYSIS(72476-852) , MANUFACTURE(72476-852)
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