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NDC 42126-6500-01 Oasis TEARS PF PLUS 0.25 g/100mL Details

Oasis TEARS PF PLUS 0.25 g/100mL

Oasis TEARS PF PLUS is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by OASIS Medical, Inc.. The primary component is GLYCERIN.

Product Information

NDC	42126-6500
Product ID	42126-6500_df0ae8bb-543d-4681-823f-9a9c4ae90537
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Oasis TEARS PF PLUS
Proprietary Name Suffix	Preservative-Free Lubricant Eye
Non-Proprietary Name	Glycerin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.25
Active Ingredient Units	g/100mL
Substance Name	GLYCERIN
Labeler Name	OASIS Medical, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42126-6500-01 (42126650001)

Pricing Information	N/A
NDC Package Code	42126-6500-1
Billing NDC	42126650001
Package	1 BOTTLE, DISPENSING in 1 CARTON (42126-6500-1) / 10 mL in 1 BOTTLE, DISPENSING
Marketing Start Date	2021-06-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Glycerin (0.25%)

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

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

Protect from light and freezing
Store at or below 77°F/25°C

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

INGREDIENTS AND APPEARANCE

OASIS TEARS PF PLUS PRESERVATIVE-FREE LUBRICANT EYE

glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42126-6500
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	0.25 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42126-6500-1	1 in 1 CARTON	06/10/2021
1		10 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	06/10/2021

Labeler - OASIS Medical, Inc. (194121018)

Name	Address	ID/FEI	Business Operations
Establishment
EXCELVISION		274234566	MANUFACTURE(42126-6500)

Revised: 5/2021

Document Id: df0ae8bb-543d-4681-823f-9a9c4ae90537

Set id: 5d080191-423d-4c0a-b5ae-2ccf5c4a67cb

Version: 1

Effective Time: 20210519