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 Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 seals on top and bottom flaps are intact and clearly legible.
  
• Use before expiration date marked on container.
  
• Discard 90 days after opening
  
• Store at 59°-86°F (15°-30°C).
  
• RETAIN THIS CARTON 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

refreshbrand.com

PRINCIPAL DISPLAY PANEL

Refresh
Tears®
Lubricating Eye Drops
MOISTURIZING RELIEF
Immediate, soothing
relief for dry eyes
0.5 fl oz (15 mL) Sterile

INGREDIENTS AND APPEARANCE

REFRESH TEARS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 0023-0798-04	1 in 1 CARTON	05/16/1997
1		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0023-0798-03	1 in 1 CARTON	05/16/1997
2		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0023-0798-15	1 in 1 CARTON	05/16/1997
3		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 0023-0798-01	2 in 1 CARTON	05/16/1997
4		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC: 0023-0798-02	4 in 1 CARTON	05/16/1997
5		15 mL in 1 BOTTLE, DROPPER; 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	05/16/1997

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Business Operations
Allergan Sales, LLC		362898611	MANUFACTURE(0023-0798)