NDC 65785-034 Eyewash Station Additive Concentrate

Chlorhexidine Gluconate And Propylene Glycol

NDC Product Code 65785-034

NDC CODE: 65785-034

Proprietary Name: Eyewash Station Additive Concentrate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chlorhexidine Gluconate And Propylene Glycol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 65785 - Niagara Pharmaceuticals Inc.
    • 65785-034 - Eyewash Station Additive Concentrate

NDC 65785-034-01

Package Description: .236 L in 1 BOTTLE, UNIT-DOSE

NDC Product Information

Eyewash Station Additive Concentrate with NDC 65785-034 is a a human over the counter drug product labeled by Niagara Pharmaceuticals Inc.. The generic name of Eyewash Station Additive Concentrate is chlorhexidine gluconate and propylene glycol. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Niagara Pharmaceuticals Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Eyewash Station Additive Concentrate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PROPYLENE GLYCOL 280 kg/2800L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Niagara Pharmaceuticals Inc.
Labeler Code: 65785
FDA Application Number: part349 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-15-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Eyewash Station Additive Concentrate Product Label Images

Eyewash Station Additive Concentrate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


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




A preservative for use in potable self-contained emergency eyewash stations


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 chemicalsdo not reuse

Otc - Ask Doctor

  • Stop use and ask a doctor if you have any of the followingchanges in visioneye paincondition worsens or persistscontinued 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.


  • Wear protective eyewear and glovesclean potable eyewash station and rinse with potable waterpartially fill station with potable waterremove tamper evident seal and cap of bottleadd entire contents of the bottle to the eyewash station containerfill the station to the manufacturer's required leveldate and initial inspection tagstation should be cleaned and refilled every 120 days when using this productin advance of emergency, add the concentrate to potable water to have a solution available

Other Information

  • Lot number is printed on the bottlestore 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 brokenuse before expiration date marked on bottle

Questions ?

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

* Please review the disclaimer below.