FDA Label for Eyewash Station Additive Concentrate

View Indications, Usage & Precautions

Eyewash Station Additive Concentrate Product Label

The following document was submitted to the FDA by the labeler of this product Niagara Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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™


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