LEADER DRY EYE RELIEF EYE DROPS- glycerin, hypromellose, polyethylene glycol liquid

Leader Dry Eye Relief Eye Drops by

Drug Labeling and Warnings

Leader Dry Eye Relief Eye Drops by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

PURPOSE

​Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

INDICATIONS & USAGE

​Uses

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

WARNINGS

​Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

When using this product

• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• remove contact lens before using

Stop use and ask a doctor if you experience

• eye pain
• changes in vision
• continued redness or irritation of the eye, or if the condition worsens or persists for 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.

DOSAGE & ADMINISTRATION

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed
• Children under 6 years of age, ask doctor

OTHER SAFETY INFORMATION

Other information

Store at 15o-30oC (59o-86oF)

INACTIVE INGREDIENT

​Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic 

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER DRY EYE RELIEF EYE DROPS 
glycerin, hypromellose, polyethylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0502
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	0.2 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0502-1	1 in 1 CARTON	04/30/2019
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 70000-0502-2	2 in 1 CARTON	04/30/2019
2		15 mL in 1 BOTTLE, PLASTIC; 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	manufacture(70000-0502) , pack(70000-0502) , label(70000-0502)