LEADER LUBRICANT EYE DROPS 30CT- polyethylene glycol 400, propylene glycol liquid

Leader Lubricant Eye Drops 30ct by

Drug Labeling and Warnings

Leader Lubricant Eye Drops 30ct by is a Otc medication manufactured, distributed, or labeled by KC Pharmaceuticals, Inc., K.C. Pharmaceuticals, Inc., Unimed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

Lubricant

Lubricant

Use

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

Warnings

For external use only

Do not use

• if the solution changes color or becomes cloudy
• if you are sensative 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 or lasts more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

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

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 ingredients

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

Questions or comments?

Call 1-888-527-4276

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER LUBRICANT EYE DROPS 30CT 
polyethylene glycol 400, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-017
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A)	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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-017-01	30 in 1 BOX	07/18/2019
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	07/18/2019

Labeler - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	pack(55651-017) , label(55651-017)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed		689852052	manufacture(55651-017)