Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 23, 2020

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Antihistamine

  • USE

    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° to 25°C (36° to 77°F)

  • INACTIVE INGREDIENTS

    Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Edetate disodium, Hydrochloric acid/Sodium hydroxide (adjust pH), Povidone, Sodium chloride, and Water for Injection.

  • QUESTIONS?

    contact Gland Pharma at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • PRINCIPAL DISPLAY PANEL

    NDC 68083-231-01
    Olopatadine Hydrochloride
    Ophthalmic Solution, USP
    0.2%
    Bottle Label:
    olopatadine-spl-bottle     
    Olopatadine Hydrochloride
    Ophthalmic Solution, USP
    0.2%
    C    arton Label:
    olopatadine-SPL-carton     














     

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
    olopatadine hydrochloride ophthalmic solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68083-231
    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)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68083-231-011 in 1 CARTON05/20/2020
    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
    ANDAANDA20975205/20/2020
    Labeler - Gland Pharma Limited (918601238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gland Pharma Limited918601238ANALYSIS(68083-231) , MANUFACTURE(68083-231) , PACK(68083-231)
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