NDC 79008-002 Hand Sanitizer Green

Alcohol

NDC Product Code 79008-002

NDC 79008-002-01

Package Description: 1000 mL in 1 BOTTLE

NDC 79008-002-02

Package Description: 220 mL in 1 BOTTLE

NDC 79008-002-03

Package Description: 1000 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Hand Sanitizer Green with NDC 79008-002 is a a human over the counter drug product labeled by Grupo Delveg, S.a. De C.v.. The generic name of Hand Sanitizer Green is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Grupo Delveg, S.a. De C.v.

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 Sanitizer Green 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

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: Grupo Delveg, S.a. De C.v.
Labeler Code: 79008
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: 09-27-2020 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 Sanitizer Green Product Label Images

Hand Sanitizer Green 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(S)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help to decrease bacteria on the skin that could cause disease. Recommended for repeted use.

Warnings

For external use only: hands. Flammable. Keep away from fire or flame.

Otc - When Using

Keep out of eyes, in case of contact, flush thoroughly with water. Avoid contact with broken skin. Do not inhale nor ingest.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash appears and lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed, get medical help or contact a Poisson Control Center immediately.

Directions

  • Put enough product in hands to cover them, rub them together briskly until dry.Children under 6 years old need adult supervision to use this product.

Other Information

  • Store in a cool, dry place at a temperature from 32°F to 95°F.

Inactive Ingredients

Carbomer, demineralized water, disodium EDTA, glycerin and triethanolamine.

* Please review the disclaimer below.