OASIS TEARS 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.

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Oasis TEARS® Preservative-Free Lubricant Eye Drops

Drug Facts

Active Ingredients

Glycerin (0.22%)

Purpose

Lubricant Eye Drops

Uses

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

Questions, or to report an adverse event call

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

Other Information

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 0.3 mL Pouch Carton

N 42126-6100-1

Oasis
TEARS®

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 Pouch Carton
OASIS TEARS  PRESERVATIVE-FREE LUBRICANT EYE
glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42126-6100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin.22 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Hyaluronate Sodium (UNII: YSE9PPT4TH) 0.15 g  in 100 mL
Sodium chloride (UNII: 451W47IQ8X)  
Sodium phosphate, monobasic, unspecified form (UNII: 3980JIH2SW)  
Sodium phosphate, dibasic, unspecified form (UNII: GR686LBA74)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42126-6100-13 in 1 CARTON11/01/2017
110 in 1 POUCH
10.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:42126-6100-25 in 1 POUCH11/01/2017
20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/01/2007
Labeler - OASIS Medical, Inc. (194121018)
Establishment
NameAddressID/FEIBusiness Operations
LABORATOIRE UNITHER COUTANCES574139809MANUFACTURE(42126-6100)
Establishment
NameAddressID/FEIBusiness Operations
UNITHER MANUFACTURING LLC079176615MANUFACTURE(42126-6100)

Revised: 4/2021
Document Id: 1ef317c1-aad4-4b95-ac9e-14fde3028135
Set id: d9d71b1d-82a6-42e7-9ef2-2d041daef936
Version: 3
Effective Time: 20210421
 
OASIS Medical, Inc.