LEADER LUBRICANT EYE- polyethylene glycol, propylene glycol solution/ drops

leader lubricant eye by

Drug Labeling and Warnings

leader lubricant eye by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each single-use container)

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purpose

Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• do not reuse
• once opened, discard

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persist or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• instill 1 or 2 drops in the affected eye(s) as needed

Other information

• store at 20-25°C (68-77°F)
• protect from light

Inactive ingredients

boric acid, calcium chloride dihydrate, hypromellose, magnesium chloride hexahydrate, potassium chloride, sodium chloride, water for injection, zinc chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Sterile

Lubricant Eye Drops

Polyethylene Glycol 0.4%

Propylene Glycol 0.3%

Actual Size

COMPARE TO SYSTANE® active ingredients

Dry Eye Therapy

100% Money Back Guarantee

Long Lasting Relief

Preservative Free

30 STERILE SINGLE-USE VIALS

0.4 mL (0.01 FL OZ) EACH

INGREDIENTS AND APPEARANCE

LEADER LUBRICANT EYE 
polyethylene glycol, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0351
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0351-1	30 in 1 CARTON	04/18/2018
1		0.4 mL in 1 VIAL; 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	04/18/2018

Labeler - Cardinal Health (097537435)