FDA.reportPublic FDA data

Oasis TEARS ® PF PLUS Preservative-Free Lubricant Eye Drops

Manufacturer
OASIS Medical, Inc. | LABORATOIRE UNITHER COUTANCES
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:15

Label at a glance#

ProductOasis TEARS PF PLUS Preservative-Free Lubricant Eye
Active ingredientGLYCERIN
Label structure10 sections

Indications and 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

Dosage and administration

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

Storage and handling

protect from light and freezing. store between 41°F (5°C) and 77°F (25°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin (0.25%)

Purpose

OTC - PURPOSE SECTION

lubricant Eye Drops

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Questions, or to report an adverse event call

OTC - QUESTIONS SECTION

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

Other Information

STORAGE AND HANDLING SECTION

  • protect from light and freezing.
  • store between 41°F (5°C) and 77°F (25°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OASIS
TEARS®

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

PF PLUS

NDC 42126-6500-1

Principal Display Panel - 10 mL Bottle Carton
Principal Display Panel - 10 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310541glycerin 0.25 % Ophthalmic SolutionPSN5
1598052Oasis TEARS PF 0.25 % Ophthalmic SolutionPSN5
1598052glycerin 2.5 MG/ML Ophthalmic Solution [Oasis Tears]SBD5
310541glycerin 2.5 MG/ML Ophthalmic SolutionSCD5
310541glycerin 0.25 % Ophthalmic SolutionSY5
1598052Oasis Tears PF 0.25 % Ophthalmic SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42126-6500-1Oasis TEARS PF PLUSPreservative-Free Lubricant Eye10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS105
42126-6500-1Oasis TEARS PF PLUSPreservative-Free Lubricant Eye1 in 1 CARTONSOLUTION/ DROPS15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42126-650042126-6500-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
ndc (package): 42126-6500-1
ndc (product): 42126-6500
ndc11 (package): 42126650001
spl id: 343d2203-409f-49f0-91d9-7249927f5eac
spl set id: 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.