Label: OLOPATADINE- olopatadine hydrochloride solution/ drops

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

Drug Label Information

Updated February 3, 2022

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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 the 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 at 4° to 25°C (39° 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?

    Call toll-Free 1-800-932-5676 weekdays, 7:00 AM - 5:30 PM CST

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-312-12

    Olopatadine HCl Ophthalmic

    Solution, USP 0.2%

    Antihistamine

    ONCE DAILY

    STERILE 2.5 mL (0.085 FL OZ)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Original NDC 17478-312-12

    Prescription

    Strength Akorn logo

    Olopatadine

    HCl Ophthalmic

    Solution, USP

    0.2%

    Antihistamine

    Eye Allergy Itch Relief

    Works in Minutes

    Relief from Allergens:

    • Pet Dander

    • Pollen

    • Grass

    • Ragweed

    ONCE DAILY

    STERILE

    2.5 mL (0.085 FL OZ)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    OLOPATADINE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-312
    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, unspecified form (UNII: GR686LBA74)  
    edetate disodium (UNII: 7FLD91C86K)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    povidone, unspecified (UNII: FZ989GH94E)  
    sodium chloride (UNII: 451W47IQ8X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-312-121 in 1 CARTON09/01/2021
    12.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20472309/01/2021
    OLOPATADINE 
    olopatadine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-305
    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, unspecified form (UNII: GR686LBA74)  
    edetate disodium (UNII: 7FLD91C86K)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    povidone, unspecified (UNII: FZ989GH94E)  
    sodium chloride (UNII: 451W47IQ8X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-305-112 in 1 CARTON09/01/2021
    12.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20472309/01/2021
    Labeler - Akorn (117696770)
    Registrant - AKORN OPERATING COMPANY LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840LABEL(17478-312, 17478-305) , MANUFACTURE(17478-312, 17478-305) , PACK(17478-312, 17478-305) , ANALYSIS(17478-312, 17478-305) , STERILIZE(17478-312, 17478-305)
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