EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid

Eyewash Station Additive Concentrate by

Drug Labeling and Warnings

Eyewash Station Additive Concentrate by is a Otc medication manufactured, distributed, or labeled by Encon Safety Products, Inc., Niagara Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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 1-800-283-6266 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 - 236 mL Bottle Label

INGREDIENTS AND APPEARANCE

EYEWASH STATION ADDITIVE CONCENTRATE 
chlorhexidine gluconate and propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70290-120
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70290-120-01	0.237 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	12/02/2020
2	NDC: 70290-120-05	0.946 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	12/02/2020
3	NDC: 70290-120-06	3.786 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	12/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	12/02/2020

Labeler - Encon Safety Products, Inc. (008102410)

Registrant - Niagara Pharmaceuticals Inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals Inc.		205477792	manufacture(70290-120)