LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS- polyethylene glycol, propylene glycol liquid

Leader Preservative-Free Ultra Lubricating Eye Drops by

Drug Labeling and Warnings

Leader Preservative-Free Ultra Lubricating Eye Drops by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, KC Pharmaceuticals, Inc., Unimed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Polyethylene glycol 400  0.4%
Propylene glycol   0.3%

PURPOSE

Purpose

Polyethylene glycol 400............. Lubricant
Propylene glycol............ Lubricant

INDICATIONS & USAGE

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

WARNINGS

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 the 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, persists or lasts more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
Instill 1 or 2 drops in the affected eye(s) as needed

OTHER SAFETY INFORMATION

Other information

• store at 15°-25°C (59°-77°F)
• use only if single-use container is intact
• use before expiration date marked on container
• RETAIN THIS CARTON FOR FUTURE REFERENCE

INACTIVE INGREDIENT

Inactive ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride.  May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

QUESTIONS

Questions or comments?  Call 1-888-527-4276

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS 
polyethylene glycol, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0501
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0501-1	25 in 1 BOX	04/30/2019
1		0.4 mL in 1 VIAL, SINGLE-USE; 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	04/30/2019

Labeler - Cardinal Health (097537435)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(70000-0501) , label(70000-0501)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed		689852052	manufacture(70000-0501)