NDC 75010-150 Terrapure Hand Sanitizer

Ethyl Alcohol

NDC Product Code 75010-150

NDC 75010-150-01

Package Description: 100 mL in 1 BOTTLE

NDC 75010-150-02

Package Description: 1000 mL in 1 BOTTLE, PUMP

NDC 75010-150-03

Package Description: 3780 mL in 1 BOTTLE

NDC Product Information

Terrapure Hand Sanitizer with NDC 75010-150 is a a human over the counter drug product labeled by Mirfeel Korea Co., Ltd. The generic name of Terrapure Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Mirfeel Korea Co., 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.

Terrapure Hand Sanitizer 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.

  • GLYCERIN (UNII: PDC6A3C0OX)

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: Mirfeel Korea Co., Ltd
Labeler Code: 75010
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: 11-01-2020 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.

Terrapure Hand Sanitizer 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

Active Ingredients / Ingrédient actifEthyl Alcohol 70.0% (w/w)Alcool Éthylique 70%

Inactive Ingredients

Inactive Ingredients / Ingrédients inactifsGlycerol, Polyacrylic Acid, Nitrilotrisethanol, Dihydrogen PeroxideGlycérol, Acide Polyacrylique, Nitrilotrisethanol, Oxyde de Dihydrogène

Purpose

Purpose/ObjectifAntiseptic / Antiseptiqu

Warnings

Warnings / AvertissementsFlammable. Keep away from open flame and sources of heat. For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult healthcare professional if irritation develops. Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away. Store below 110F (43C). May discolour certain fabrics or surfaces.Inflammable. Tenir à l’écart des flames nues et des sources de chaleur. Pour usage externe uniquement. Lors de l’utilisation de ce produit, évitez tout contact avec les yeux. Enc as de contact, rincer abondamment à l’eau. Arrêtez l’utilisation et consultez un professionnel de la santé si une irritation se développe. Tenir hors de portée des enfants. En cas d’ingestion, appeler un centre antipoison ou obtenir immédiatement une aide médicale. Conserveren dessous de 110F (43C). Peut décolorer certain tissus ou surfaces.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Use / UsageHelps reduce bacteria on the skin that could cause diseases.Aide à éliminer les bactéries sur la peau qui peuvent causer des maladies.

Directions

Directions / Mode d'emploiPress pump twice and rub throughout into hands for at least 30 seconds. Allow to dry. Children under 6 years of age should be supervised when using this product.Appuyez deux fois sur la pompe et frottez-vous soigneusement dans les mains pendant au moins 30 secondes. Laissez sécher. Les enfants de moins de 6 ans doivent êtres surveillés lorsqu'ils utilisent ce produit.

* Please review the disclaimer below.