LEADER LUBRICATING EYE- carboxymethylcellulose sodium, and glycerin solution/ drops

LEADER LUBRICATING EYE by

Drug Labeling and Warnings

LEADER LUBRICATING EYE by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                           Purpose

Carboxymethylcellulose Sodium 0.5%----------------------- Lubricant

Glycerin 0.9%------------------------------------------------- Lubricnat

PURPOSE

Uses

• For the temporary relief of burning, irritation and discomfort due to dryness of the eye or from irritation from wind or sun.
• May be used to protect against further irritation

WARNINGS

Warnings

• For external use only

WHEN USING

When using this product

• To avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
• Do not use if solution changes color or gets cloudy.

STOP USE

Stop use and ask a doctor if

You feel eye pain, changes in vision, continued redness, or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Directions

Put 1 or 2 drops in the affected eye(s) as needed.

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium citrate dihydrate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4290763

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER LUBRICATING EYE 
carboxymethylcellulose sodium, and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-635
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	5 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORATE DIHYDRATE (UNII: BBB2RG413E)
ERYTHRITOL (UNII: RA96B954X6)
LEVOCARNITINE (UNII: 0G389FZZ9M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-635-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/04/2012

Labeler - CARDINAL HEALTH (097537435)