NDC 78806-200 All Clean Natural Antibacterial Foaming Hand Wash

0.13% Benzalkonium Chloride Solution

NDC Product Code 78806-200

NDC CODE: 78806-200

Proprietary Name: All Clean Natural Antibacterial Foaming Hand Wash 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: 0.13% Benzalkonium Chloride Solution 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

  • 78806 - All Clean Natural Ltd.
    • 78806-200 - All Clean Natural Antibacterial Foaming Hand Wash

NDC 78806-200-01

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC Product Information

All Clean Natural Antibacterial Foaming Hand Wash with NDC 78806-200 is a a human over the counter drug product labeled by All Clean Natural Ltd.. The generic name of All Clean Natural Antibacterial Foaming Hand Wash is 0.13% benzalkonium chloride solution. The product's dosage form is soap and is administered via topical form.

Labeler Name: All Clean Natural Ltd.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

All Clean Natural Antibacterial Foaming Hand Wash 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 .013 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.

  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • ALOE (UNII: V5VD430YW9)
  • CUCUMBER (UNII: YY7C30VXJT)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

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: All Clean Natural Ltd.
Labeler Code: 78806
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: 01-31-2021 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: 12-31-2022 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.

All Clean Natural Antibacterial Foaming Hand Wash Product Label Images

All Clean Natural Antibacterial Foaming Hand Wash 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 Ingredients/ Ingrédients Actifs

Benzalkonium Chloride 0.13%/ Chlorure de benzalkonium 0.13%

Purpose

Antiseptic skin cleanser/ Nettoyant antiseptique

Use / Usage

Antiseptic skin cleanser/ Nettoyant antiseptique pour la peau

When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water/ Lorsque vous utilisez ce produit éviter tout contact avec les yeux. Le cas échéant, bien rincer avec de l'eau.

Stop Use

Stop use and ask a doctor if irritation develops / Cessez d'utiliser et consultez un médecin si une irritation se développe

Keep Out Of Reach Of Children

Keep out of reach of children. / Garder hors de la portée des enfants.

If Swallowed

If swallowed, call a poison control centre or get medical help right away. / En cas d'ingestion, appeler immédiatement un centre antipoison ou obtenir une assistance médicale

Directions / Mode D'emploi

If swallowed, call a poison control centre or get medical help right away. / En cas d'ingestion, appeler immédiatement un centre antipoison ou obtenir une assistance médicale

Inactive Ingredients/ Ingrédients Inactifs

Aqua, Caprylyl Glucoside, Vegetable Glycerin, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate, Cucumber Peel Botanical Extract, Aloe vera juice, Vitamin E, parfum

* Please review the disclaimer below.