ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol and povidone liquid

Artificial Tears Lubricant Eye by

Drug Labeling and Warnings

Artificial Tears Lubricant Eye by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
  
• Tamper Evident: do not use if neckband on bottle is broken or missing.

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)

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS LUBRICANT EYE 
polyvinyl alcohol and povidone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-181
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	5.0 mg  in 1 mL
POVIDONES (UNII: FZ989GH94E) (POVIDONES - UNII:FZ989GH94E)	POVIDONES	6.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-181-01	1 in 1 BOX
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/01/2012

Labeler - Prestige Brands Holdings, Inc. (159655021)