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NDC 42126-6310-01 OASIS Tears 2 g/1000mL Details

OASIS Tears 2 g/1000mL

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	42126-6310
Product ID	42126-6310_fdbf7d44-f8a3-4109-a9b2-3ee48b78b9df
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	Lubricant Eye
Non-Proprietary Name	Glycerin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	2
Active Ingredient Units	g/1000mL
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 42126-6310-01 (42126631001)

Pricing Information	N/A
NDC Package Code	42126-6310-1
Billing NDC	42126631001
Package	1 BOTTLE, DISPENSING in 1 CARTON (42126-6310-1) / 10 mL in 1 BOTTLE, DISPENSING
Marketing Start Date	2010-01-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 00071697-4ac6-4962-8eee-388b8b52bd40 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

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

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.

SPL UNCLASSIFIED SECTION

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

EDTA, potassium sorbate, sodium chloride, sodium hyaluronate, sodium hydroxide, sodium phosphate dibasic, sodium phosphate monobasic, water

PRINCIPAL DISPLAY PANEL - 10mL Bottle Carton

Oasis

TEARS ®

LUBRICANT EYE DROPS

VISCOADAPTIVE...RELIEF

FOR DRY EYES

10mL/0.3 fl. oz.

INGREDIENTS AND APPEARANCE

OASIS TEARS LUBRICANT EYE

glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42126-6310
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42126-6310-1	1 in 1 CARTON	01/09/2010
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	01/09/2010

Labeler - OASIS Medical, Inc. (194121018)

Name	Address	ID/FEI	Business Operations
Establishment
Excelvision		274234566	pack(42126-6310) , manufacture(42126-6310)

Revised: 2/2018

Document Id: fdbf7d44-f8a3-4109-a9b2-3ee48b78b9df

Set id: 00071697-4ac6-4962-8eee-388b8b52bd40

Version: 4

Effective Time: 20180202

Search by Drug Name or NDC

NDC 42126-6310-01 OASIS Tears 2 g/1000mL Details

OASIS Tears 2 g/1000mL

Product Information

Package

Package Images

NDC 42126-6310-01 (42126631001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 00071697-4ac6-4962-8eee-388b8b52bd40 Details

SPL UNCLASSIFIED SECTION

Active Ingredients

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Directions

SPL UNCLASSIFIED SECTION

Other information

Inactive Ingredients

PRINCIPAL DISPLAY PANEL - 10mL Bottle Carton

INGREDIENTS AND APPEARANCE

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