KOLLOURION EYESALVE EYEWASH- purified water 98.3% solution

Kollourion Eyesalve Eyewash by

Drug Labeling and Warnings

Kollourion Eyesalve Eyewash by is a Otc medication manufactured, distributed, or labeled by Miracle Eye Pharmaceuticals, Niagara Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Purified Water 98.3%

PURPOSE

Purpose

Eyewash

INDICATIONS & USAGE

Use

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

WARNINGS

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
• continued redness or irritation of the eye
• condition worsens or persists

• eye pain
• changes in vision

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

OTHER SAFETY INFORMATION

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 INGREDIENT

Inactive ingredients

boric acid, sodium borate, sodium chloride

QUESTIONS

Call 1-973-568-3361 9am to 5pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOLLOURION EYESALVE EYEWASH 
purified water 98.3% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72924-001(NDC:65785-160)
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: 72924-001-01	1 in 1 CARTON	12/01/2020
1		30 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
OTC Monograph Drug	M018	12/01/2020

Labeler - Miracle Eye Pharmaceuticals (080055386)

Establishment
Name	Address	ID/FEI	Business Operations
Miracle Eye Pharmaceuticals		080055386	repack(72924-001)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals Inc		205477792	manufacture(72924-001)