EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid 
Encon Safety Products, 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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HYDROSEP POTABLE WATER 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

Other information

Questions ?

☎ Call 1-800-283-6266 9 a.m. to 5 p.m. EST Mon-Fri

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PDP-Drug Facts

EYEWASH STATION ADDITIVE CONCENTRATE 
chlorhexidine gluconate and propylene glycol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70290-120
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE145.6 kg  in 2800 L
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL280 kg  in 2800 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 2374.4 L  in 2800 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70290-120-010.237 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
2NDC:70290-120-050.946 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
3NDC:70290-120-063.786 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34912/02/2020
Labeler - Encon Safety Products, Inc. (008102410)
Registrant - Niagara Pharmaceuticals Inc. (205477792)
Establishment
NameAddressID/FEIBusiness Operations
Niagara Pharmaceuticals Inc.205477792manufacture(70290-120)

Revised: 12/2020
Document Id: b5a621c1-ea1a-f533-e053-2a95a90a541a
Set id: b5a62567-c9f1-0492-e053-2a95a90ab247
Version: 1
Effective Time: 20201204
 
Encon Safety Products, Inc.