LEADER EYE WASH- purified water liquid

Leader Eye Wash by

Drug Labeling and Warnings

Leader Eye Wash by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, KC Pharmaceuticals, Inc., Bausch & Lomb Incorperated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Purified water (99.05%)

Purpose

Eyewash

Uses

washes the eye to help relieve

• irritation
• discomfort
• burning
• stinging
• itching

by removing

• loose foreign material
• air pollutants (smog or pollen)
• chlorinated water

Warnings

For external use only

Do not use

• if you have open wounds in or near the eyes, and get medical help right away
• if solution changes color or becomes cloudy

When using this product

• remove contact lenses before using
• do not touch tip of container to any surface to avoid contamination
• replace cap after use

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness or irritation of the eye
• condition worsens or persists

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

For use with nozzle applicator.

• flush the affected eye(s) as needed
• control the rate of flow of solution by pressure on the bottle

do not touch dropper tip to eye

When using an eye cup

• rinse the cup with Eye Wash Solution immediately before each use
• avoid contamination of the rim and inside surfaces of the cup
• fill the cup half full with Eye Wash Solution and apply the cup to affected eye(s), pressing tightly to prevent spillage
• tilt the head backward. Open eyelids wide and rotate eyeballs to thoroughly wash the eye
• rinse cup with clean water after each use
• replace cap after use

Other information

• store at 15°-25°C (59°-77°F)
• keep tightly closed
• does not contain thimerosal
• enclosed eyecup is sterile if packaging is intact
• use before expiration date marked on the carton or bottle

Inactive ingredients

boric acid, sodium borate and sodium chloride.

PRESERVATIVE ADDED: benzalkonium chloride (0.01%)

Questions or comments?

Toll free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-888-527-4276

Leader Eye Wash

INGREDIENTS AND APPEARANCE

LEADER EYE WASH 
purified water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0018
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0018-1	1 in 1 BOX	07/09/2019
1		118 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	07/09/2019

Labeler - Cardinal Health (097537435)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorperated		114406598	manufacture(70000-0018)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(70000-0018) , label(70000-0018)