Label: OLOPATADINE HYDROCHLORIDE solution

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

Drug Label Information

Updated August 21, 2020

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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?

    ✆1-855-274-44122

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India
    Code: TS/DRUGS/13/2010

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

    PrimaryHealth                             NDC 58602-012-40
    Olopatadine Hydrochloride
    Ophthalmic Solution, USP
    0.1%
    Antihistamine and Redness Reliever
    Eye Allergy Itch & Redness Relief
    STERILE                                     5 mL (0.17 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)

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

                                                          NDC 58602-012-40
                                                                PrimaryHealth
                                  *Compare to the Active Ingredient
                                         in Pataday® Once Daily Relief
    NOW AVAILABLE without a prescription
    Olopatadine Hydrochloride
    Ophthalmic Solution, USP
    0.1%
    Antihistamine and Redness Reliever
    Eye Allergy Itch & Redness Relief
    Works in Minutes
    Relief from Allergens:
    • Pet Dander • Pollen                     TWICE
    • Grass • Ragweed                          DAILY
                                                         STERILE
                                          5 mL (0.17 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-012
    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:58602-012-401 in 1 CARTON07/15/2020
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20481207/15/2020
    Labeler - Aurohealth LLC (078728447)
    Registrant - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650498244ANALYSIS(58602-012) , MANUFACTURE(58602-012)
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