REFRESH TEARS- carboxymethylcellulose sodium solution/ drops

REFRESH TEARS by

Drug Labeling and Warnings

REFRESH TEARS by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants, Inc., Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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.
• To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• 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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Use only if imprinted tape seal on bottle is intact and clearly legible.
• Use before expiration date marked on container.
• Store at 59°-86°F (15°-30°C).
• RETAIN THIS CARD FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1.800.433.8871 M–F 6 AM – 4:30 PM Pacific Time
refreshbrand.com

SPL UNCLASSIFIED SECTION

Repackaged and distributed by Convenience Valet®
Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 3 mL Bottle Label

CONVENIENCE
CV
VALET®

PERSONAL
CARE

Refresh
Tears®
Lubricant Eye Drops

0.1 fl oz (3 mL) Sterile

INGREDIENTS AND APPEARANCE

REFRESH TEARS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-1073(NDC:0023-0798)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
boric acid (UNII: R57ZHV85D4)
calcium chloride (UNII: M4I0D6VV5M)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
water (UNII: 059QF0KO0R)
sodium chlorite (UNII: G538EBV4VF)
sodium chlorate (UNII: T95DR77GMR)
chlorine dioxide (UNII: 8061YMS4RM)
sodium borate (UNII: 91MBZ8H3QO)
sodium chloride (UNII: 451W47IQ8X)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-1073-0	1 in 1 PACKAGE
1		3 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	01/01/2010

Labeler - Mechanical Servants, Inc. (005530951)

Establishment
Name	Address	ID/FEI	Business Operations
Allergan, Inc.		362898611	MANUFACTURE(29485-1073)

Establishment
Name	Address	ID/FEI	Business Operations
Mechanical Servants, Inc.		005530951	RELABEL(29485-1073)