CLEAR EYES TRAVELERS EYE RELIEF- polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Clear Eyes Travelers Eye Relief by

Drug Labeling and Warnings

Clear Eyes Travelers Eye Relief 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

Active ingredient

Tetrahydrozoline hydrochloride 0.05%

Purpose

Redness Reliever

Uses

• For the temporary relief of burning & irritation due to the dryness of the eye.
  
• For use as a protectant against further irritation or to relieve dryness of the eye.
  
• Relieves redness of the eye due to minor eye irritations.

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.
  
• Overuse may produce increased redness of the eye.
  
• Pupils may become enlarged temporarily.

Stop use & 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) up to four times daily.

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, dibasic sodium phosphate, edatate disodium, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate

Questions?

1-877-274-1787 www.cleareyes.com

PRINCIPAL DISPLAY PANEL

Clear eyes® Traveler’s EYE RELIEF
Lubricant/Redness Reliever Eye Drops
STERILE 0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

Clear eyes® Traveler’s EYE RELIEF
Lubricant/Redness Reliever Eye Drops
0.2 FL OZ (6 mL) 

INGREDIENTS AND APPEARANCE

CLEAR EYES TRAVELERS EYE RELIEF 
polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-584
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
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-584-01	1 in 1 BOX	11/15/2011
1		6 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

CLEAR EYES TRAVELERS EYE RELIEF 
polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-585
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
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-585-01	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(67172-585, 67172-584)