OTC Medication Information: OASIS Tears Plus Preservative-Free Lubricant Eye

OASIS TEARS PLUS PRESERVATIVE-FREE LUBRICANT EYE- glycerin solution/ drops
OASIS Medical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 conditions 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) and above 32°F (0°C).

Inactive Ingredients

Sodium chloride, sodium hyaluronate, 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

PRINCIPAL DISPLAY PANEL -- 0.3 ML Vial Pouch Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Glycerin (Glycerin) Glycerin 0.22 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Hyaluronate Sodium 0.3 g in 100 mL
Sodium chloride
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42126-6200-1 3 POUCH in 1 CARTON contains a POUCH
1 10 VIAL, SINGLE-USE in 1 POUCH This package is contained within the CARTON (42126-6200-1) and contains a VIAL, SINGLE-USE
1 0.3 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a CARTON (42126-6200-1)
2 NDC:42126-6200-2 5 VIAL, SINGLE-USE in 1 POUCH contains a VIAL, SINGLE-USE
2 0.3 mL in 1 VIAL, SINGLE-USE This package is contained within the POUCH (42126-6200-2)
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 Operations
LABORATOIRE UNITHER COUTANCES 574139809 MANUFACTURE (42126-6200)
Establishment
Name Address ID/FEI Operations
UNITHER MANUFACTURING LLC 079176615 MANUFACTURE (42126-6200)

Revised: 05/2021 OASIS Medical, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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