CLEAR EYES OUTDOOR DRY EYE PROTECTION- polyvinyl alcohol and povidone liquid

Clear Eyes Outdoor Dry Eye Protection by

Drug Labeling and Warnings

Clear Eyes Outdoor Dry Eye Protection by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc., Aspen SVP Pty Ltd. 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.

Ask a doctor before use if you have

narrow angle glaucoma.

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 (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
  
• 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 www.cleareyes.com

PRINCIPAL DISPLAY PANEL

Clear eyes
ALL SEASONS OUTDOOR
Dry Eye Protection
Lubricant Eye Drops
STERILE 0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

CLEAR EYES OUTDOOR DRY EYE PROTECTION 
polyvinyl alcohol and povidone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-686
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 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: 67172-686-01	1 in 1 BOX	11/15/2011
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	11/15/2011

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen SVP Pty Ltd		569162139	MANUFACTURE(67172-686)