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NDC 13985-0609-04 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 MWI. The primary component is WATER.

Product Information

NDC	13985-0609
Product ID	13985-609_e98fc587-9a9e-48c0-beeb-6d30b027f0af
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	MWI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022305
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13985-0609-04 (13985060904)

Pricing Information	N/A
NDC Package Code	13985-609-04
Billing NDC	13985060904
Package	1 BOTTLE in 1 BOTTLE (13985-609-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2015-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1fa0cc05-37ce-4d61-8060-fd89a5d449d2 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 20° to 25° C [68° to 77° 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 888-628-0581

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 13985-609-04

Ophthalmic

Solution

Eyewash

Purified Water, 98.3%

STERILE SOLUTION

Single Use

APEXA logo

AP 704011

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:13985-609
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:13985-609-04	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	02/23/2015

Labeler - MWI (019926120)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Niagara Pharmaceuticals, Inc.		205477792	manufacture(13985-609)

Revised: 10/2020

Document Id: e98fc587-9a9e-48c0-beeb-6d30b027f0af

Set id: 1fa0cc05-37ce-4d61-8060-fd89a5d449d2

Version: 4

Effective Time: 20201026