Label: OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION solution

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

Drug Label Information

Updated April 14, 2025

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  • Active ingredient

    Olopatadine (0.2%)

    (equivalent to olopatadine hydrochloride 0.222%)

  • Purpose

    Antihistamine

  • Uses

    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 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 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 4 —25 °C (39 —77 °F)
    • protect from light
  • Inactive ingredients

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

  • Questions?

    Call 1-800-910-6874

  • Principle Display Panel

    TARGET 2PECENT CARTON

    NDC: 82442-967-02

    20077500
    JE61705

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION 
    olopatadine hydrochloride ophthalmic solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82442-967
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82442-967-021 in 1 CARTON04/15/2025
    13.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20608704/15/2025
    Labeler - TARGET CORPORATION (006961700)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625manufacture(82442-967)
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