FDA.reportPublic FDA data

Eyewash Station Additive Concentrate

Manufacturer
Encon Safety Products, Inc. | Niagara Pharmaceuticals Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:04:11

Label at a glance#

ProductEyewash Station Additive Concentrate
Active ingredientCHLORHEXIDINE GLUCONATE, PROPYLENE GLYCOL
Label structure10 sections

Dosage and administration

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 ad...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Product Information

Ingredients

OTC - ACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Preservative

Use

INDICATIONS & USAGE SECTION

A preservative for use in potable self-contained emergency eyewash stations

Warnings

WARNINGS SECTION

For external use only. In case of contact with eye in undiluted form, flush with clean water

Do not use

OTC - DO NOT USE SECTION

  • in full strength

When using this product

OTC - WHEN USING SECTION

  • do not change dilution or use with other chemicals
  • do not reuse

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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 ?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP-Drug FactsPDP-Drug Facts

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70290-120-012025-01-30C16284748780-12cef2736-afc4-d83d-e063-dadaa90ab31fHYDROSEP POTABLE WATER ADDITIVE
70290-120-052025-01-30C16284748780-12cef2736-afc4-d83d-e063-dadaa90ab31fHYDROSEP POTABLE WATER ADDITIVE
70290-120-062025-01-30C16284748780-12cef2736-afc4-d83d-e063-dadaa90ab31fHYDROSEP POTABLE WATER ADDITIVE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70290-12070290-120-01, 70290-120-05, 70290-120-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5a621c1-ea1a-f533-e053-2a95a90a541ab5a62567-c9f1-0492-e053-2a95a90ab2472020-12-04WarningsExact identifier
spl id: b5a621c1-ea1a-f533-e053-2a95a90a541a
spl set id: b5a62567-c9f1-0492-e053-2a95a90ab247

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.