Label: ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    Eye lubricant

  • Uses

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

  • Warnings

    • Do not use if imprinted seal on the bottle neck is broken or missing.
    • Do not use if solution changes color or becomes cloudy.
    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.

    Stop use and ask a doctor if

    condition persists or increases discontinue use and consult a veterinarian.

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • Other information

    • Store at 20° to 25°C (68° to 77°F)
      [see USP Controlled Room Temperature].
    • Store away from heat.
    • Protect from freezing.
    • Keep tightly closed.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

  • Questions?

    call toll-free 1-800-932-5676

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 59399-160-15

    15 mL

    ARTIFICIAL

    TEARS

    SOLUTION

    Polyvinyl Alcohol 1.4%

    Lubricant Eye Drops

    For Veterinary Use

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 59399-160-15

    Akorn Animal Health Logo

    15 mL

    ARTIFICIAL

    TEARS

    SOLUTION

    Polyvinyl Alcohol 1.4%

    Lubricant Eye Drops

    For Veterinary Use

    Prevents Irritation and

    Relieves Dryness

    of the Eye

    Sterile

    15 mL (0.5 fl. oz.)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59399-160
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) (Polyvinyl Alcohol, Unspecified - UNII:532B59J990) Polyvinyl Alcohol, Unspecified14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59399-160-151 in 1 CARTON
    115 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/15/2015
    Labeler - Akorn (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Avantor Performance Materials International, Inc.152791026API MANUFACTURE
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