CLEAR EYES MAXIMUM REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid

Clear Eyes Maximum Redness Relief by

Drug Labeling and Warnings

Clear Eyes Maximum 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 the dryness of the eye.
  
• for the 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:

• pupils may become enlarged temporarily
  
• overuse may produce increased redness of the eye
  
• remove contact lenses before using
  
• to avoid contamination, do not touch tip of container 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 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

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Questions?

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

PRINCIPAL DISPLAY PANEL

Clear eyes®
MAXIMUM
REDNESS RELIEF
LUBRICANT/REDNESS
RELIEVER EYE DROPS
STERILE 0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

CLEAR EYES MAXIMUM REDNESS RELIEF 
naphazoline hydrochloride and glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-696
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-696-01	1 in 1 CARTON	09/01/2010
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 67172-696-02	1 in 1 CARTON	09/01/2010
2		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	09/01/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
Aspen SVP Pty Ltd		569162139	MANUFACTURE(67172-696)