Pur-Wash (Water) Solution [Niagara Pharmaceuticals Inc.] -

PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]
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NDC	65785-162-01, 65785-162-02
Set ID	777e1559-786f-8d54-e053-2991aa0aa98d
Category	HUMAN OTC DRUG LABEL
Packager	Niagara Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number	NDA022305

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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 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri
SPL UNCLASSIFIED SECTION

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

INGREDIENTS AND APPEARANCE

PUR-WASH
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:65785-162-01	236 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011
2	NDC:65785-162-02	473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011

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

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Name	Address	ID/FEI	Business Operations
Establishment
Niagara Pharmaceuticals Inc.		205477792	manufacture(65785-162)

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Medic