Eyewash Station Additive Concentrate

Manufacturer
Niagara Pharmaceuticals Inc. | STERIS Applied Sterilization Technologies ULC | Isomedix Operations Inc.
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:17:45

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 ifyou 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 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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™

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65785-034-012023-02-21C16284748780-1f386c64a-201f-0266-e053-dadaa90a7c1aEYEWASH STATION ADDITIVE CONCENTRATE
65785-034-012023-01-30C16284748780-1f386c64a-201f-0266-e053-dadaa90a7c1aEYEWASH STATION ADDITIVE CONCENTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65785-034-01Eyewash Station Additive Concentrate0.236 L in 1 BOTTLE, UNIT-DOSELIQUID0.2368

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Chlorhexidine gluconateACTIVE INGREDIENTMOR84MUD8E1
Propylene GlycolACTIVE INGREDIENT6DC9Q167V31
ChlorhexidineACTIVE MOIETYR4KO0DY52L1
Propylene GlycolACTIVE MOIETY6DC9Q167V31
WaterINACTIVE INGREDIENT059QF0KO0R1

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
65785-03465785-034-01

Ingredients#

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

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

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
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
ndc (package): 65785-034-01
ndc (product): 65785-034
ndc11 (package): 65785003401
spl id: 445cd72e-831c-98c4-e063-6294a90a7bdc
spl set id: 362a6b6d-862d-4322-87a8-5b3a07fbe174

Reported adverse events (FAERS/openFDA)#

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