Label: CLEAR EYES NATURAL TEARS- polyvinyl alcohol and povidone liquid

  • NDC Code(s): 67172-557-02
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 May 22, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Polyvinyl alcohol 0.5%

  • Purpose

    Lubricant

  • Active ingredient

    Povidone 0.6%

  • Purpose

    Lubricant

  • Uses

    • for the temporary relief of burning and irritation 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 of container 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 lasts for more than 72 hours        

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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       www.cleareyes.com 


  • PRINCIPAL DISPLAY PANEL

    Clear eyes® Natural Tears
    Lubricating Eye Drops
    STERILE 0.5 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL
Clear eyes® Natural Tears
Lubricating Eye Drops 
STERILE 0.5 FL OZ (15 mL) 
     

  • INGREDIENTS AND APPEARANCE
    CLEAR EYES NATURAL TEARS 
    polyvinyl alcohol and povidone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-557
    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 (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67172-557-021 in 1 BOX05/15/2013
    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 FINALpart34905/15/2013
    Labeler - Prestige Brands Holdings, Inc. (159655021)