NDC 81281-001 Eco-foam Hand Sanitizer

Benzalkonium Chloride Solution

NDC Product Code 81281-001

NDC 81281-001-01

Package Description: 250 mL in 1 BOTTLE

NDC 81281-001-02

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Eco-foam Hand Sanitizer with NDC 81281-001 is a a human over the counter drug product labeled by 11989693 Canada Inc.. The generic name of Eco-foam Hand Sanitizer is benzalkonium chloride solution. The product's dosage form is solution and is administered via topical form.

Labeler Name: 11989693 Canada Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Eco-foam Hand Sanitizer 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.

  • BENZALKONIUM CHLORIDE 1.3 mg/mL

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.

  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: 11989693 Canada Inc.
Labeler Code: 81281
FDA Application Number: part333A 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: 12-16-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Eco-foam Hand Sanitizer 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

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic Skin Cleanser

Uses

Antiseptic skin cleanserEffective in destroying harmful bacteria to provide antiseptic cleansing

Warnings

For external use only

When Using This Product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor

If irritation develops.

Keep Out Of Reach Of Children

If swallowed, call a Posion Control Center or get medical help right away.

Directions

Adults and children over 2 years. For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds.Allow to dry.

Other Information

Store at room temperature

Inactive Ingredients

Cocamidopropyl betaine, Glycerin, Lauramine oxide, Propylene glycol, Water

Questions?

Telephone (514) 548-2187

* Please review the disclaimer below.