Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION- olopatadine hydrochloride ophthalmic solution/ drops

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

Drug Label Information

Updated June 26, 2023

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  • ACTIVE INGREDIENT

    Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 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 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) 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 and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

  • QUESTIONS?

    Call 1-888-375-3784

  • PRINCIPAL DISPLAY PANEL

    Olopatadine Hydrochloride
    Ophthalmic Solution USP, 0.1%

    Carton

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
    olopatadine hydrochloride ophthalmic solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1308
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1308-401 in 1 CARTON01/05/2021
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20961901/05/2021
    Labeler - Rugby Laboratories (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reed Lane Inc.001819879pack(0536-1308)
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