EQUATE RESTORE TEARS- carboxymethylcellulose sodium solution/ drops

Equate Restore Tears by

Drug Labeling and Warnings

Equate Restore Tears by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Equate

Restore Tears Drops

49035-189-49

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 use in the eyes only.

● Retain outer carton for full product drug facts

Do not use

● If solution changes color, or becomes cloudy.

When using this product

● avoid contamination, do not touch tip of container

   to any surface.

● replace cap after each use.

Stop use and ask a doctor if

● you experience eye pain, changes in vision, continued 

   redness or irritation of the eye(s)

● the condition worsens or persists for more than 72 hours.

Keep out of the reach of children.

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

Directions

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

Other Information

● store at room temperature 15º -30ºC (59º-86ºF).

● keep tightly closed.

Inactive ingredients

Boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium borate, sodium chloride, water for injection. Vanish® (Stabilized Peroxycomplex System as a preservative). May also contain hydrochloric acid and or sodium hydroxide to adjust pH.

Questions?

1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-189-49
equate
Restore Tears Drops
LUBRICANT EYE DROPS
CARBOXYMETHYCELLULOSE SODIUM 0.5%
Sterile
2 – 0.5 fl oz (15mL) BOTTLES
1 FL OZ (30mL) TOTAL

INGREDIENTS AND APPEARANCE

EQUATE RESTORE TEARS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-189
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)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
CHLORINE DIOXIDE (UNII: 8061YMS4RM)
POLIHEXANIDE (UNII: 322U039GMF)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	HYDROCHLORIC ACID (UNII: QTT17582CB)
May contain	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-189-49	2 in 1 CARTON	04/10/2014
1		15 mL in 1 BOTTLE; 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	04/10/2014

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Altaire Pharmaceuticals, Inc. (786790378)