NDC 80511-001 Hand Sanitzer

Ethyl Alcohol

NDC Product Code 80511-001

NDC 80511-001-01

Package Description: 50 mL in 1 BOTTLE

NDC 80511-001-02

Package Description: 50 mL in 1 BOTTLE

NDC 80511-001-03

Package Description: 80 mL in 1 BOTTLE

NDC 80511-001-04

Package Description: 236 mL in 1 BOTTLE

NDC 80511-001-05

Package Description: 500 mL in 1 BOTTLE

NDC 80511-001-06

Package Description: 1000 mL in 1 BOTTLE

NDC 80511-001-07

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Hand Sanitzer with NDC 80511-001 is a a human over the counter drug product labeled by Luxe Decor Sales Ltd. The generic name of Hand Sanitzer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Luxe Decor Sales Ltd

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.

Hand Sanitzer 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 740 mL/1000mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Luxe Decor Sales Ltd
Labeler Code: 80511
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: 09-04-2020 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.

Hand Sanitzer Product Label Images

Hand Sanitzer 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 74% v/v

Purpose

Ethyl Alcohol 74% v/v................Antiseptic

Uses

Highly effective alcohol-based hand sanitizing gel which sanitizes the skin without the need for water.

Warnings

For external use only.

Flammable. Keep away from flame and heat.

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

Otc - Keep Out Of Reach Of Children

Keep away from children. If swallowed, call a Poison Control Centre or a doctor. Supervise children using this product.

Otc - Stop Use

Stop use and ask a doctor if irritation develops

Directions

Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry

Other Information

Store below 40°C (100°F).

Inactive Ingredients

Water, glycerin, carbomer, triethanolamine

* Please review the disclaimer below.