PUR-WASH- water solution

PUR-WASH by

Drug Labeling and Warnings

PUR-WASH by is a Otc medication manufactured, distributed, or labeled by Niagara Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088
• 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

• snap off ridged tamper-evident tip
• 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 973-568-3361 9 a.m. to 5 p.m. EST Mon-Fri

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Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Pur-Wash

Purified Water, 98.3%

Ophthalmic Solution

Eyewash

Single Use

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

Made in Canada

Sterile Solution

4 Fl Oz [118 mL]

INGREDIENTS AND APPEARANCE

PUR-WASH 
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65785-169
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: 65785-169-01	30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011
2	NDC: 65785-169-04	118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022305	09/12/2011

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals Inc.		205477792	manufacture(65785-169)