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

LEADER LUBRICANT EYE DROPS
carboxymethylcellulose sodium solution/ drops

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	07/13/2019

Labeler - Cardinal Health (063997360)

Registrant - KC Pharmaceuticals, Inc. (174450460)

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

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

Leader Lubricant Eye Drops 70ct and 30ct (PLD)