CLEAR EYES COOLING REDNESS RELIEF- glycerin and naphazoline hydrochloride liquid

Clear Eyes Cooling Redness Relief by

Drug Labeling and Warnings

Clear Eyes Cooling Redness Relief by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc., ASPEN SA STERILE OPERATIONS PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Glycerin 0.5%

Purpose

Lubricant

Active ingredients

Naphazoline hydrochloride 0.03%

Purpose

Redness Reliever

Uses

• For the relief of redness of the eye due to minor eye irritations.
  
• For the temporary relief of burning and irritation due to dryness of the eye.
  
• For use as a protectant against further irritation or 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 of container 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 or persists 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, boric acid, cyclodextrin, edetate disodium, menthol, purified water, sodium borate

Questions?

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

 

PRINCIPAL DISPLAY PANEL

NEW Clear eyes® 
COOLING COMFORT
Lubricant/Redness Relief Eye Drops
REDNESS RELIEF
Cools Eye Irritations
Relieves Redness
STERILE 0.5 FL OZ (15 ML)

INGREDIENTS AND APPEARANCE

CLEAR EYES COOLING REDNESS RELIEF 
glycerin and naphazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-393
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.3 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
BETADEX (UNII: JV039JZZ3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-393-01	1 in 1 BOX	02/15/2011
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	02/15/2011

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen SVP Pty Ltd		569162139	MANUFACTURE(67172-393)