Lubricating Plus (Carboxymethylcellulose Sodium) Solution/ Drops [Major Pharmaceuticals] -

LUBRICATING PLUS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [MAJOR PHARMACEUTICALS]
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NDC	0904-6329-46, 0904-6329-51, 0904-6329-58
Set ID	e1e95b7f-9282-4642-af7e-5d0c11ce6bd9
Category	HUMAN OTC DRUG LABEL
Packager	Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number	PART349

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Active ingredient (in each single-use container)

Carboxymethylcellulose sodium 0.5%
Purpose

Eye lubricant
Uses

•

for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun

•

may be used as a protectant against further irritation
Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

When using this product

to avoid contamination

•

do not touch tip of container to any surface

•

do not reuse

•

once opened, discard

•

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 reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions

•

to open, twist and pull tab to remove

•

instill 1 or 2 drops in the affected eye(s) as needed and discard container
Other information

•

store at 20-25°C (68-77°F)

•

RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive ingredients

calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium lactate solution, water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions or comments?

1-800-616-2471
Package/Label Principal Display Panel

COMPARE TO the active ingredient of REFRESH PLUS®

Lubricating PLUS

Lubricant Eye Drops

Immediate, soothing relief for dry eyes

Moisturizing Relief

Carboxymethylcellulose Sodium 0.5%

30 Sterile Single-Use Containers

0.01 FL OZ (0.4 mL) each

Actual Size

INGREDIENTS AND APPEARANCE

LUBRICATING PLUS
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6329
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)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6329-46	6 in 1 CARTON	05/09/2013
1		5 in 1 POUCH
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:0904-6329-51	10 in 1 CARTON	05/31/2013
2		5 in 1 POUCH
2		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
3	NDC:0904-6329-58	14 in 1 CARTON	05/31/2013	10/01/2014
3		5 in 1 POUCH
3		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product