Label: ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol and povidone liquid

  • NDC Code(s): 67172-181-01
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Polyvinyl alcohol 0.5%

    Povidone 0.6%

  • Purpose

    Lubricant

  • Uses

    • For the temporary relief of burning & irritations due to dryness of the eye.
    • For use as a protectant against further irritation or to relieve dryness of the eye.
  • Warnings

    For external use only

    Do not use if

    solution changes color or becomes cloudy.

    When using this product:

    • to avoid contamination, do not touch tip to any surface.
    • replace cap after using.

    Stop use and ask a doctor if:

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens
    • symptoms last 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

    • Instill 1 to 2 drops in the affected eye(s) as needed.
  • Other information

    • Store at room temperature
    • Remove contact lenses before using
  • Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

  • Questions?

    1-877-274-1787

  • PRINCIPAL DISPLAY PANEL

    Sterile
    Artificial Tears
    Lubricant Eye Drops
    0.5 FL OZ (15 mL)

    Sterile Artificial Tears Lubricant Eye Drops 0.5 FL OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS LUBRICANT EYE 
    polyvinyl alcohol and povidone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-181
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5.0 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-181-011 in 1 BOX06/01/2012
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01806/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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