OASIS TEARS LUBRICANT EYE- glycerin solution/ drops

OASIS Tears by

Drug Labeling and Warnings

OASIS Tears by is a Otc medication manufactured, distributed, or labeled by OASIS Medical, Inc., Excelvision. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Glycerin (0.22%)

Purpose

lubricant Eye Drops

Uses

• For the temporary relief of burning and irritation due to dryness of the eye
• For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
• For use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

• If solution changes color or becomes cloudy
• If you are sensitive to any ingredient in this product

When using this product

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

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.

QUESTIONS

Questions, or to report an adverse event call:

(800) 631-7180 or (909) 305-5400 or log onto www.oasistears.com

Other information

• Protect from light and freezing
• Store at or below 77°F/25°C

Inactive Ingredients

EDTA, potassium sorbate, sodium chloride, sodium hyaluronate, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic, water

PRINCIPAL DISPLAY PANEL - 10mL Bottle Carton

Oasis

TEARS ®

LUBRICANT EYE DROPS

VISCOADAPTIVE...RELIEF

FOR DRY EYES

10mL/0.3 fl. oz.

INGREDIENTS AND APPEARANCE

OASIS TEARS   LUBRICANT EYE
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42126-6310
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42126-6310-1	1 in 1 CARTON	01/09/2010
1		10 mL in 1 BOTTLE, DISPENSING; 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	01/09/2010

Labeler - OASIS Medical, Inc. (194121018)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	pack(42126-6310) , manufacture(42126-6310)