Label: EYEWASH STATION ADDITIVE CONCENTRATE- chlorhexidine gluconate and propylene glycol liquid

  • NDC Code(s): 70290-120-01, 70290-120-05, 70290-120-06
  • Packager: Encon Safety Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 4, 2020

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  • SPL UNCLASSIFIED SECTION

    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 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

    PDP-Drug Facts

  • INGREDIENTS AND APPEARANCE
    EYEWASH STATION ADDITIVE CONCENTRATE 
    chlorhexidine gluconate and propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70290-120
    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:70290-120-010.237 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
    2NDC:70290-120-050.946 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
    3NDC:70290-120-063.786 L in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34912/02/2020
    Labeler - Encon Safety Products, Inc. (008102410)
    Registrant - Niagara Pharmaceuticals Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals Inc.205477792manufacture(70290-120)
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