OASIS TEARS PLUS PRESERVATIVE-FREE LUBRICANT EYE- glycerin solution/ drops

OASIS Tears Plus by

Drug Labeling and Warnings

OASIS Tears Plus by is a Otc medication manufactured, distributed, or labeled by OASIS Medical, Inc., LABORATOIRE UNITHER COUTANCES, UNITHER MANUFACTURING LLC. 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
• For use as a lubricant to prevent 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
• Once opened, discard
• Do not reuse

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, 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

Sodium hyaluronate, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, water.

PRINCIPAL DISPLAY PANEL - 0.3 ML Vial Pouch Carton

N 42126-6200-1

Oasis
TEARS® PLUS

PRESERVATIVE-FREE
LUBRICANT EYE DROPS

VISCOADAPTIVE RELIEF
FOR DRY EYES

30
STERILE (0.3 ML/0.01 FL. OZ.)
SINGLE USE CONTAINERS

INGREDIENTS AND APPEARANCE

OASIS TEARS PLUS   PRESERVATIVE-FREE LUBRICANT EYE
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42126-6200
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	0.22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Hyaluronate Sodium (UNII: YSE9PPT4TH)	0.3 g  in 100 mL
Sodium chloride (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42126-6200-1	3 in 1 CARTON	11/01/2007
1		10 in 1 POUCH
1		0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 42126-6200-2	5 in 1 POUCH	11/01/2007
2		0.3 mL in 1 VIAL, SINGLE-USE; 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	11/01/2007

Labeler - OASIS Medical, Inc. (194121018)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		194121018	MANUFACTURE(42126-6200)

Establishment
Name	Address	ID/FEI	Business Operations
OASIS Medical, Inc.		024362989	PACK(42126-6200)