REFRESH CELLUVISC - carboxymethylcellulose sodium solution/ drops
Allergan, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Carboxymethylcellulose sodium 1%

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.
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.
If solution changes color or becomes cloudy, do not use.

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Use only if single-use container is intact.
REFRESH® CELLUVISC® may cause temporary blurring due to its viscosity.
Store at 59°-86°F (15°-30°C).
Use before expiration date marked on container.
RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Calcium chloride, potassium chloride, purified water, sodium chloride, and sodium lactate.

Questions or comments?

1.800.433.8871, M-F 6 AM - 4:30 PM Pacific Time

refreshbrand.com

REFRESH®CELLUVISC®

Lubricant Eye Drops

Allergan, Inc.

Irvine, CA 92612

NDC 0023-4554-30

SENSITIVE

Preservative-free

Refresh®

Celluvisc®

Lubricant Eye Drops

Extra thick gel

drops for dry eyes

®ALLERGAN

30 Single-Use Containers

0.01 fl oz (0.4 mL) each Sterile

REFRESH CELLUVISC
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0023-4554
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (carboxymethylcellulose)	carboxymethylcellulose sodium	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
calcium chloride
potassium chloride
water
sodium chloride
sodium lactate

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0023-4554-05	5 VIAL, SINGLE-USE (5 VIAL) in 1 CARTON	contains a VIAL, SINGLE-USE
1		0.4 mL in 1 VIAL, SINGLE-USE	This package is contained within the CARTON (0023-4554-05)
2	NDC:0023-4554-30	30 VIAL, SINGLE-USE (30 VIAL) in 1 CARTON	contains a VIAL, SINGLE-USE
2		0.4 mL in 1 VIAL, SINGLE-USE	This package is contained within the CARTON (0023-4554-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/04/1989

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 06/2011 Allergan, Inc.