CLEAR EYES TRIPLE ACTION- polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Clear Eyes Triple Relief by

Drug Labeling and Warnings

Clear Eyes Triple Relief 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%

Active ingredients

Povidone 0.6%

Purpose

Lubricant

Active ingredient

Tetrahydrozoline hydrochloride 0.05%

Purpose

Redness reliever

Uses

• for the temporary relief of burning & irritation due to 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

Inactive ingredients

benzalkonium chloride, dextrose, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate

PRINCIPAL DISPLAY PANEL

Clear eyes®
TRIPLE ACTION
LUBRICANT/REDNESS
RELIEVER EYE DROPS

STERILE 0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

CLEAR EYES TRIPLE ACTION 
polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-898
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: 67172-898-01	1 in 1 BOX	03/15/2011
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	03/15/2011

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen SVP Pty Ltd		569162139	MANUFACTURE(67172-898)