OPTHALMIC SOLUTION EYEWASH- water solution

Opthalmic Solution Eyewash by

Drug Labeling and Warnings

Opthalmic Solution Eyewash by is a Animal medication manufactured, distributed, or labeled by Hikma Pharmaceuticals USA Inc., 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 833-850-7445

SPL UNCLASSIFIED SECTION

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 86194-001-50

OPHTHALMIC
SOLUTION
EYEWASH

Purified Water, 98.3%

FOR ANIMAL USE ONLY

Single Use

Distributed by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

EVAAL/01

Rev. 10/23

Made in Canada

Sterile Solution

4 fl.oz. (118 mL)

hikma.

animal health

INGREDIENTS AND APPEARANCE

OPTHALMIC SOLUTION EYEWASH 
water solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86194-001
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 CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86194-001-50	30 mL in 1 BOTTLE, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/20/2025

Labeler - Hikma Pharmaceuticals USA Inc. (001230762)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals Inc.		205477792	manufacture, api manufacture