Label: CLEAR EYES ONCE DAILY EYE ALLERGY ITCH RELIEF- olopatadine hydrochloride solution/ drops

  • NDC Code(s): 67172-504-01
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 9, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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 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° - 25°C (36° - 77°F)
  • Inactive ingredients

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

  • Questions?

    1-877-274-11787 Cleareyes.com

    TAMPER EVIDENT: For your protection, this bottle has a ring around the neck. Do not use if ring is separated from cap, damaged, or missing at time of purchase.

  • PRINCIPAL DISPLAY PANEL

    CLEAR EYES®

    ---- ONCE DAILY ----

    EYE ALLERGY ITCH RELIEF

     

    OLOPATADINE HYDROCHLORIDE
    OPHTHALMIC SOLUTION USP, 0.2%
    ANTIHISTAMINE

     

    Sterile 2.5 mL (0.085 FL OZ)

    PRINCIPAL DISPLAY PANEL CLEAR EYES® ---- ONCE DAILY ---- EYE ALLERGY ITCH RELIEF OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.2% ANTIHISTAMINE Sterile 2.5 mL (0.085 FL OZ)

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES ONCE DAILY EYE ALLERGY ITCH RELIEF 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-504
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-504-011 in 1 CARTON09/15/2021
    12.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09084809/15/2021
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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