TOPCARE LUBRICATING PLUS- carboxymethylcellulose sodium solution/ drops

Topcare Lubricating Plus by

Drug Labeling and Warnings

Topcare Lubricating Plus by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

SENSITIVE PRESERVATIVE FREE

Lubricating Plus

Lubricant Eye Drops

CARBOXYMETHYLCELLULOSE SODIUM 0.5%

Moisture drops for dry eyes

Actual Size

COMPARE TO REFRESH PLUS® active ingredient

30 SINGLE-USE CONTAINERS

0.01 FL OZ (0.4 mL) EACH STERILE

INGREDIENTS AND APPEARANCE

TOPCARE LUBRICATING PLUS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-323
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-323-01	14 in 1 CARTON	08/20/2013	12/01/2016
1		5 in 1 POUCH
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 36800-323-65	6 in 1 CARTON	09/04/2013
2		5 in 1 POUCH
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	08/20/2013

Labeler - Topco Associates LLC (006935977)