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NDC 42126-6100-01 OASIS Tears 0.22 g/100mL Details

OASIS Tears 0.22 g/100mL

OASIS Tears 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	42126-6100
Product ID	42126-6100_1ef317c1-aad4-4b95-ac9e-14fde3028135
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
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	0.22
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 42126-6100-01 (42126610001)

Pricing Information	N/A
NDC Package Code	42126-6100-1
Billing NDC	42126610001
Package	3 POUCH in 1 CARTON (42126-6100-1) / 10 VIAL, SINGLE-USE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2017-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9d71b1d-82a6-42e7-9ef2-2d041daef936 Details

SPL UNCLASSIFIED SECTION

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 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

INGREDIENTS AND APPEARANCE

OASIS TEARS PRESERVATIVE-FREE LUBRICANT EYE

glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42126-6100
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	.22 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42126-6100-1	3 in 1 CARTON	11/01/2017
1		10 in 1 POUCH
1		0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:42126-6100-2	5 in 1 POUCH	11/01/2017
2		0.3 mL in 1 VIAL, SINGLE-USE; 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	11/01/2007

Labeler - OASIS Medical, Inc. (194121018)

Name	Address	ID/FEI	Business Operations
Establishment
LABORATOIRE UNITHER COUTANCES		574139809	MANUFACTURE(42126-6100)

Name	Address	ID/FEI	Business Operations
Establishment
UNITHER MANUFACTURING LLC		079176615	MANUFACTURE(42126-6100)

Revised: 4/2021

Document Id: 1ef317c1-aad4-4b95-ac9e-14fde3028135

Set id: d9d71b1d-82a6-42e7-9ef2-2d041daef936

Version: 3

Effective Time: 20210421