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

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 11, 2020

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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 FINALpart34906/01/2012
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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