Eyewash Station Additive Concentrate Liquid
FDA Label NDC 65785-034

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Niagara Pharmaceuticals Inc. for the product Eyewash Station Additive Concentrate (NDC 65785-034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, inactive ingredient, purpose, use, warnings, do not use, when using this product, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Product Information

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

Inactive Ingredient

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

Otc - Ask Doctor

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

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

Principal Display Panel - 236 Ml Bottle Label

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)

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