Eyewash Station Additive Concentrate (Chlorhexidine Gluconate And Propylene Glycol) Liquid [Niagara Pharmaceuticals Inc.] -

EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]
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NDC	65785-034-01
Set ID	362a6b6d-862d-4322-87a8-5b3a07fbe174
Category	HUMAN OTC DRUG LABEL
Packager	Niagara Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number	PART349

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Product Information
Ingredients

Chlorhexidine gluconate 1% w/v Purified Water, Propylene Glycol
Purpose

Preservative
Use

A preservative for use in potable self-contained emergency eyewash stations
Warnings
For external use only. In case of contact with eye in undiluted form, flush with clean water
Do not use
- in full strength
When using this product
- do not change dilution or use with other chemicals
- do not reuse
Stop use and ask a doctor if you have any of the following
- 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
- wear protective eyewear and gloves
- clean potable eyewash station and rinse with potable water
- partially fill station with potable water
- remove tamper evident seal and cap of bottle
- add entire contents of the bottle to the eyewash station container
- fill the station to the manufacturer's required level
- date and initial inspection tag
- station should be cleaned and refilled every 120 days when using this product
- in advance of emergency, add the concentrate to potable water to have a solution available
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
Questions ?

☎ Call 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri
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Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

EYEWASH STATION
ADDITIVE
CONCENTRATE

NDC 65785-034-01

A preservative for potable water.
Preserves from 5 - 20 US Gallons
(15 - 76 Liters)

FOR USE IN EMERGENCY
EYEWASH STATIONS.

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3
Made in Canada

8 Fl Oz [236 mL]

HEALTH SAVER®

The Safe Solution™

INGREDIENTS AND APPEARANCE

EYEWASH STATION ADDITIVE CONCENTRATE
chlorhexidine gluconate and propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65785-034
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	145.6 kg in 2800 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	280 kg in 2800 L

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	2374.4 L in 2800 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65785-034-01	0.236 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	11/15/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part349	11/15/2011

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Registrant - Niagara Pharmaceuticals Inc. (205477792)

Name	Address	ID/FEI	Business Operations
Establishment
Niagara Pharmaceuticals Inc.		205477792	manufacture(65785-034)

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Medic

EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]

Do not use

When using this product

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