NDC 80457-004 Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean


NDC Product Code 80457-004

NDC CODE: 80457-004

Proprietary Name: Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean 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: Alcohol 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

  • 80457 - Adex Cosmetics & Pharma Leszek Sierdzinski
    • 80457-004 - Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean

NDC 80457-004-01

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean with NDC 80457-004 is a a human over the counter drug product labeled by Adex Cosmetics & Pharma Leszek Sierdzinski. The generic name of Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Adex Cosmetics & Pharma Leszek Sierdzinski

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean 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.

  • ALCOHOL 70 mL/100mL

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)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: Adex Cosmetics & Pharma Leszek Sierdzinski
Labeler Code: 80457
FDA Application Number: part333E 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: 03-01-2021 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 - 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.

Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean Product Label Images

Anti-bacter Hand Sanitizer 70 Ethyl Alcohol Med-clean 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

Ethyl alcohol 70% v/v




  • For travel, shopping, school, work and home useto help reduce bacteria on the skinfor use when water and soap are not availablerecommended for repeated uses


  • For external use only: handsflammable, keep away from sources of heat or fire

Do Not Use

  • On broken, cut or irritated skin

Keep Out Of Reach Of Children.

  • Avoid contact with eyes. if contact occurs, rinse thoroughly with water,

Stop Using And Ak A Doctor

  • If irritation or redness develops or lastsif swallowed, get medical help or contact a Poison Control Center immediately


  • Place enough gel in your palms to thoroughly cover hand, rub hands together brikly until drychildren under 6 years of age should be supervised when using Anti-Bacter Hand Sanitizernot recommended for infants

Other Information

  • Store at a temperature below 104°F (40°C)may discolor certain fabrics and surfaces

Inactive Ingredients:

Water, glycerin, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer or carbomer*, parfum, aminomethyl propanol, potassium sorbate, sodium benzoate, linalol,limonene.

*The letter next to the batch number means:

A-acrylates/C10-30 alkyl acrylate crosspolymer B-carbomer

* Please review the disclaimer below.