Eyewash (Water) Solution [Mwi] -

EYEWASH (WATER) SOLUTION [MWI]
PDF | XML

View All Sections

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)

INGREDIENTS AND APPEARANCE

EYEWASH
water solution

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

#	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)

View All Sections

Medic