NDC 80683-001 Luvone Hand Sanitizer With Glycerin


NDC Product Code 80683-001

NDC 80683-001-01

Package Description: 150 mL in 1 BOTTLE

NDC Product Information

Luvone Hand Sanitizer With Glycerin with NDC 80683-001 is a a human over the counter drug product labeled by Industrias Mc Clean S A S. The generic name of Luvone Hand Sanitizer With Glycerin is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Industrias Mc Clean S A S

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.

Luvone Hand Sanitizer With Glycerin 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 .7 mL/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.

  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Industrias Mc Clean S A S
Labeler Code: 80683
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: 01-01-2021 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: 12-31-2021 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.

Luvone Hand Sanitizer With Glycerin Product Label Images

Luvone Hand Sanitizer With Glycerin 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

Ethyl Alcohol 70 %




Helps to reduce bacterias that potentially can cause disease.


  • For External Use OnlyFlammable. Keep away from the fire or flame

Keep Out Of Reach Of Children,

  • Pets and ignition sources.

Do Not Use

In Children less than 2 months, except under adult supervision• Do not use on open skin wounds

• Avoid spraying in eyes, In case of contact, rinse eyes throughly with water

• If swallowed, get medical help, or contact a Poison Control Center right away

• Use only as directed. Intentional misues by deliberately concentrating and inhaling the contents can be harmful or fatal

• Do not use over flames, do not pierce, can be fatal


Use directly on hands and spread gently

Other Information

Store at room temperature, in a cool and dry place.May discolor or damage some fabrics/materials or surfaces.

Inactive Ingredients

Water, Glycerine.

* Please review the disclaimer below.