Search by Drug Name or NDC

NDC 00404-7198-01 Eyewash 929 g/946mL Details

Eyewash 929 g/946mL

Eyewash is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein, Inc.. The primary component is WATER.

Product Information

NDC	00404-7198
Product ID	0404-7198_0de865ad-19e8-42b5-af97-58add333c737
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	Eyewash
Proprietary Name Suffix	n/a
Non-Proprietary Name	Water
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	929
Active Ingredient Units	g/946mL
Substance Name	WATER
Labeler Name	Henry Schein, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022305
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00404-7198-01 (00404719801)

Pricing Information	N/A
NDC Package Code	0404-7198-01
Billing NDC	00404719801
Package	1 BOTTLE in 1 BOTTLE (0404-7198-01) / 118 mL in 1 BOTTLE
Marketing Start Date	2015-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f7c5887c-05a3-4831-82eb-d8aea6706571 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Purified water 98.3%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only

Do not use

if you experience any open wounds in or near the eyes and obtain immediate medical treatment
if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface
do not reuse
once opened, discard

Stop use and ask a doctor if you experience

changes in vision
eye pain
condition worsens or persists
continued redness or irritation of the eye

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other information

lot number is printed on the bottle
store at 20º to 25º C [68º to 77º F]
for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL”
do not use if this seal is missing or broken
use before expiration date marked on bottle

Inactive ingredients

boric acid, sodium borate, sodium chloride

Questions ?

Call 1-800-472-4346

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

HENRY SCHEIN logo

NDC 0404-7198-01

112-7198

Ophthalmic

Solution

Eyewash

Purified Water, 98.3%

Single Use

Sterile Solution

Distributed by (in US only):

HENRY SCHEIN INC.

135 DURYEA ROAD

MELVILLE, NY 11747 USA

www.henryschein.com

BEHAAL Rev. 12/14

Made in Canada

4 fl.oz. (118 mL)

Principal Display Panel Text for Container Label

INGREDIENTS AND APPEARANCE

EYEWASH

water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-7198
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	929 g in 946 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-7198-01	1 in 1 BOTTLE	03/25/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022305	03/23/2015

Labeler - Henry Schein, Inc. (012430880)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Niagara Pharmaceuticals, Inc.		205477792	manufacture(0404-7198)

Revised: 10/2020

Document Id: 0de865ad-19e8-42b5-af97-58add333c737

Set id: f7c5887c-05a3-4831-82eb-d8aea6706571

Version: 4

Effective Time: 20201026