Eyewash by MWI / Akorn Operating Company LLC / Niagara Pharmaceuticals, Inc. EYEWASH- water solution

Eyewash by

Drug Labeling and Warnings

Eyewash by is a Otc medication manufactured, distributed, or labeled by MWI, Akorn Operating Company LLC, Niagara Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13985-609
Route of Administration	OPHTHALMIC

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	02/23/2015

Labeler - MWI (019926120)

Registrant - Niagara Pharmaceuticals, Inc. (205477792)

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