LEADER LUBRICANT EYE DROPS- carboxymethylcellulose sodium liquid

Leader Lubricant Eye Drops by

Drug Labeling and Warnings

Leader Lubricant 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 ingredients

Carboxymethylcellulose sodium 0.5%

Purpose

Lubricant

Uses

• for the temoprary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
• may be used as a protectant against further irritation

Warnings

For external use only

Do not use this product if

• solution changes color or becomes cloudy

When using this product

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

Stop use and ask a doctor if

• you experience eye pain
• changes in vision occur
• redness or irritation of the eye continues
• redness or irritation of the eye worsens or persists for more than 72 hours

Keep out of the reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1800-222-1222) immediately.

Directions

• to open, twist and pull tab to remove
• instill 1 or 2 drops in the affected eye(s) as needed and discard container
• if used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions

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

calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

Call 1-888-527-4276

Leader Lubricant Eye Drops Preservative-Free 70 ct

INGREDIENTS AND APPEARANCE

LEADER LUBRICANT EYE DROPS 
carboxymethylcellulose sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0012
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0012-1	70 in 1 BOX	07/13/2019
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 70000-0012-2	30 in 1 BOX	07/13/2019
2		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	07/13/2019

Labeler - Cardinal Health (097537435)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(70000-0012) , label(70000-0012)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed		689852052	manufacture(70000-0012) , pack(70000-0012) , label(70000-0012)