Label: OLOPATADINE HYDROCHLORIDE solution/ drops

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

Drug Label Information

Updated November 30, 2021

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  • ACTIVE INGREDIENT

    Olopatadine 0.2% (equivalent to olopatadine hydrochloride 0.222%)

  • PURPOSE

    Antihistamine

  • INDICATIONS AND USAGE

    Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dande

  • WARNINGS

    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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTION

    ●  adults and children 2 years of age and older:

    o              put 1 drop in the affected eye(s) once daily, no more than once per day

    o              if using other ophthalmic products while using this product, wait at least 5 minutes between each product

    o              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°-25°C (36°-77°F)

  • INACTIVE INGREDIENT

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

  • Questions

    Call 1-866-604-3268

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Original Prescription

    Strength

    NDC 69097-600-33

    Olopatadine

    Hydrochloride

    Ophthalmic

     Solution, USP 0.2%

    Antihistamine

    ONCE DAILY

    Eye allergy itch relief

    Works in Minutes

    Relief from Allergens:

       ● Pet Dander

       ● Pollen

    ● Grass

    ●Ragweed

    Cipla

    STERILE

    2.5 mL (0.085 FL OZ)

    carton

    NDC 69097-600-33

    Olopatadine

    Hydrochloride

    Ophthalmic Solution,

    USP, 0.2%

    Once Daily

    Antihistamine

    Eye Allergy Itch Relief

    Sterile 2.5 mL (0.085 FL OZ)

    vial
  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69097-600
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69097-600-331 in 1 CARTON03/19/2021
    12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20608703/19/2021
    Labeler - Cipla USA Inc. (078719707)
    Registrant - Cipla USA Inc. (078719707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cipla Ltd. Indore918596409ANALYSIS(69097-600) , MANUFACTURE(69097-600) , LABEL(69097-600) , PACK(69097-600)
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