ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol and povidone liquid 
Prestige Brands Holdings, Inc.

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.

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Artificial Tears Lubricant Eye Drops

Drug Facts

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Lubricant

Uses

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

Other information

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)

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)

Revised: 9/2020
Document Id: 50110024-641b-407d-a4b8-2e7c8a7d018b
Set id: 4cee7eba-8338-42c5-92ca-71c7df1bbf04
Version: 4
Effective Time: 20200911
 
Prestige Brands Holdings, Inc.