Eyewash Station Additive Concentrate by Niagara Pharmaceuticals Inc. Encon Additive

Eyewash Station Additive Concentrate by

Drug Labeling and Warnings

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

Drug Details [pdf]

EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid 
Niagara Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Encon Additive

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

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

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

EYEWASH STATION ADDITIVE CONCENTRATE 
chlorhexidine gluconate and propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65785-038
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: 65785-038-01	0.236 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	11/15/2011

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

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Registrant - Niagara Pharmaceuticals Inc. (205477792)

Establishment
Name	Address	ID/FEI	Business Operations
Niagara Pharmaceuticals Inc.		205477792	manufacture(65785-038)

Revised: 2/2022

Document Id: d736fbd6-4cfd-bc33-e053-2a95a90a26fd

34390-5

Set id: d736fbd6-4cfc-bc33-e053-2a95a90a26fd

Version: 1

Effective Time: 20220204