Physicians Care Eyewash additive

Eyewash Station Additive Concentrate by

Drug Labeling and Warnings

Eyewash Station Additive Concentrate by is a Otc medication manufactured, distributed, or labeled by Niagara Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid 
Niagara Pharmaceuticals 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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Physicians Care Eyewash 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

  • 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

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough 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: 65785-035
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: 65785-035-010.236 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product11/15/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34911/15/2011
Labeler - Niagara Pharmaceuticals Inc. (205477792)
Registrant - Niagara Pharmaceuticals Inc. (205477792)
Establishment
NameAddressID/FEIBusiness Operations
Niagara Pharmaceuticals Inc.205477792manufacture(65785-035)

Revised: 2/2022
Document Id: d736a74b-b925-8942-e053-2995a90a7f87
Set id: d736a807-11a1-7a15-e053-2995a90a4ea6
Version: 1
Effective Time: 20220204