OASIS TEARS PF 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.

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Oasis TEARS® PF PLUS
Preservative-Free Lubricant Eye Drops

Drug Facts

Active Ingredients

Glycerin (0.25%)

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
  • 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.

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

N 42126-6500-1

Oasis
TEARS® PF
PLUS

PRESERVATIVE-FREE
LUBRICANT
EYE DROPS

VISCOADAPTIVE...RELIEF
FOR DRY EYES

10mL/0.34 FL OZ Bottle

Principal Display Panel - 10 mL Bottle Carton
OASIS TEARS PF PLUS   PRESERVATIVE-FREE LUBRICANT EYE
glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42126-6500
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
sodium chloride (UNII: 451W47IQ8X)  
sodium hydroxide (UNII: 55X04QC32I)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42126-6500-11 in 1 CARTON06/10/2021
110 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/10/2021
Labeler - OASIS Medical, Inc. (194121018)
Establishment
NameAddressID/FEIBusiness Operations
EXCELVISION274234566MANUFACTURE(42126-6500)

Revised: 5/2021
Document Id: df0ae8bb-543d-4681-823f-9a9c4ae90537
Set id: 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb
Version: 1
Effective Time: 20210519
 
OASIS Medical, Inc.