NDC 80472-001 Kleanmann - Hand Sanitizer And Surface Disinfectant

Bac (benzalkonium Chloride), Ddac (didecyldimonium Chloride)

NDC Product Code 80472-001

NDC CODE: 80472-001

Proprietary Name: Kleanmann - Hand Sanitizer And Surface Disinfectant 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: Bac (benzalkonium Chloride), Ddac (didecyldimonium Chloride) 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

  • 80472 - Lamer Group Llc
    • 80472-001 - Kleanmann - Hand Sanitizer And Surface Disinfectant

NDC 80472-001-01

Package Description: 120 mL in 1 BOTTLE, SPRAY

NDC Product Information

Kleanmann - Hand Sanitizer And Surface Disinfectant with NDC 80472-001 is a a human over the counter drug product labeled by Lamer Group Llc. The generic name of Kleanmann - Hand Sanitizer And Surface Disinfectant is bac (benzalkonium chloride), ddac (didecyldimonium chloride). The product's dosage form is spray and is administered via topical form.

Labeler Name: Lamer Group Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Kleanmann - Hand Sanitizer And Surface Disinfectant 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.


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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • 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: Lamer Group Llc
Labeler Code: 80472
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: 10-01-2020 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.

Kleanmann - Hand Sanitizer And Surface Disinfectant Product Label Images

Kleanmann - Hand Sanitizer And Surface Disinfectant 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


  • This is a hand sanitizer and surface disinfectant manufactured, tested, and registered in the EU.The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation):BAC (Benzalkonium Chloride) less than 1.6%DDAC (Didecyldimonium Chloride) less than 0.4%Purified waterThe firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

BAC (Benzalkonium Chloride) less than 1.6% v/v Purpose: Skin Antiseptic:

DDAC (Didecyldimonium Chloride) less than 0.4% v/v Purpose: Food Contact Sanitizer


Antiseptic, Hand Sanitizer Spray and Surface Disinfectant


For hand and surface sanitizing to decrease harmful bacteria and viruses on the skin or frequently touched objects. Recommended for repeated use.

Do Not Use

  • Do not use in eyes. If contact occurs, flush thoroughly with water.

Otc - Stop Use

Stop use and contact a doctor if redness or irritation develops and 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.


For hand disinfection, rub the solution carefully into your palms for 30 seconds. Clean and disinfect frequently touched objects and surfaces by spraying directly on them.

Inactive Ingredients

Purified water

* Please review the disclaimer below.