Oasis Tears®

Oasis Tears®
SPL v5
SPL
SPL Set ID 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb
Route
OPHTHALMIC
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.25 g)
Inactive Ingredients
Hyaluronate Sodium Sodium Chloride Sodium Hydroxide Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-10

Description

Drug Facts

Purpose

lubricant Eye Drops


Medication Information

Purpose

lubricant Eye Drops

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only

Directions

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

Do Not Use
  • If solution changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product
Other Information
  • protect from light and freezing.
  • store between 41°F (5°C) and 77°F (25°C).
Active Ingredients

Glycerin (0.25%)

Inactive Ingredients

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

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

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

Questions, Or to Report An Adverse Event Call

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

lubricant Eye Drops

Warnings

For external use only

Directions

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

Do Not Use (Do not use)
  • If solution changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product
Other Information
  • protect from light and freezing.
  • store between 41°F (5°C) and 77°F (25°C).
Active Ingredients

Glycerin (0.25%)

Inactive Ingredients

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

When Using 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 (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

Principal Display Panel 10 Ml Bottle Carton (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

Questions, Or to Report An Adverse Event Call (Questions, or to report an adverse event call)

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


Advanced Ingredient Data


Raw Label Data

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