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

Oasis TEARS PF PLUS by

Drug Labeling and Warnings

Oasis TEARS PF PLUS 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 (0.25%)

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
• Discard 90 days after opening

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 between 41°F (5°C) and 77°F (25°C).

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

OASIS
TEARS®

LUBRICANT EYE DROPS
PRESERVATIVE-FREE
STERILE
10mL/0.33FL OZ Bottle

PF PLUS

NDC: 42126-6500-1

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42126-6500
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42126-6500-1	1 in 1 CARTON	06/10/2021
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 DRUG	M018	06/10/2021

Labeler - OASIS Medical, Inc. (194121018)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRE UNITHER COUTANCES		574139809	MANUFACTURE(42126-6500)