MedPath

Oasis Tears PF

Oasis Tears PF Preservative-Free Lubricant Eye Drops

Approved
Approval ID

640f95f4-c2e8-48ad-ad40-f76bbaddb0dc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

OASIS Medical, Inc.

DUNS: 194121018

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Glycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42126-6400
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Glycerin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (7)

GLYCERINActive
Quantity: 0.25 g in 100 mL
Code: PDC6A3C0OX
Classification: ACTIB
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

OASIS
TEARS®

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

PF

NDC 42126-6400-1

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/12/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/12/2025

Active Ingredients

Glycerin (0.25%)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/12/2025

Purpose

lubricant Eye Drops

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2025

Directions

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/12/2025

Questions, or to report an adverse event call (800) 631-7180 or or log onto www.oasismedical.com

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/12/2025

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/12/2025

Inactive Ingredients

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

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