NDC 70671-404 Handworks E2 Foam Hand Cleaner
Benzalkonium Chloride Solution Topical

Product Information

Handworks E2 Foam Hand Cleaner is a human over the counter drug product labeled by Applied Maintenance Supplies And Solutions. The generic name of Handworks E2 Foam Hand Cleaner is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Product Code70671-404
Proprietary Name 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.
Handworks E2 Foam Hand Cleaner
Non-Proprietary Name 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.
Benzalkonium Chloride
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.
Applied Maintenance Supplies And Solutions
Labeler Code70671
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-28-2016
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Handworks E2 Foam Hand Cleaner?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 70671-404-74

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

Product Details

What are Handworks E2 Foam Hand Cleaner Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

* Please review the disclaimer below.

Handworks E2 Foam Hand Cleaner Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active Ingredient

Benzalkonium Chloride 0.13%


Otc - Purpose



Purpose

Antimicrobial


Indications & Usage



Uses:

For hand washing to decrease bacteria on the skin.

Recommended for repeated use.


Warnings



Warnings:

For external use only


Otc - When Using



When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.


Otc - Stop Use



Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.


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.


Dosage & Administration



Directions:

Pump a small amount of foam into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Rinse with potable water.


Inactive Ingredient



Inactive Ingredients:

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.


Package Label.Principal Display Panel



HandWorks

E2 Foam Hand Cleaner

For Food Service and Health Care

404744

1000 ml (34 fl. oz.)

Manufactured For

Applied Maintenance Supplies and Solutions

12420 Plaza Drive, Cleveland, OH 44130

Atlanta, GA 30122  Fontana, CA 92337

www.appliedmss.com  800-458-4018



* Please review the disclaimer below.