NDC 79940-001 Thann Signature Hand Sanitising

Alcohol

NDC Product Code 79940-001

NDC 79940-001-05

Package Description: 5 mL in 1 BAG

NDC 79940-001-30

Package Description: 30 mL in 1 TUBE

NDC 79940-001-50

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Thann Signature Hand Sanitising with NDC 79940-001 is a a human over the counter drug product labeled by Formia Airline Supplies Ltd. The generic name of Thann Signature Hand Sanitising is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Formia Airline Supplies 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.

Thann Signature Hand Sanitising 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • RICE BRAN OIL (UNII: LZO6K1506A)
  • ORANGE OIL (UNII: AKN3KSD11B)

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: Formia Airline Supplies Ltd
Labeler Code: 79940
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: 10-31-2020 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.

Thann Signature Hand Sanitising Product Label Images

Thann Signature Hand Sanitising 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%

Purpose

Antiseptic

Uses

- To help reduce bacteria on the skin.

Warnings

-For external use only.


Flammable. Keep away from fire or flame.

When Using This Product

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

Stop Using And Ask A Doctor If

-Irritation and redness. Develops and lasts.

Keep Out Of Reach Of Children

-In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

-Apply a significant amount on your palm/ skin and rub until fully dry. Rinse free.

Other Information

-Store in room temperature.

Inactive Ingredients

-Aqua (Water), Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Parfum (Fragrance), Aminomethyl Propanol, Oryza Sativa (Rice) Bran Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.

* Please review the disclaimer below.