NDC 80731-001 Eco Sanitizer Liquid

Ethyl Alcohol

NDC Product Code 80731-001

NDC 80731-001-01

Package Description: 50 mL in 1 BOTTLE

NDC 80731-001-02

Package Description: 355 mL in 1 BOTTLE

NDC 80731-001-03

Package Description: 1000 mL in 1 BOTTLE

NDC 80731-001-04

Package Description: 4000 mL in 1 BOTTLE

NDC Product Information

Eco Sanitizer Liquid with NDC 80731-001 is a a human over the counter drug product labeled by 0966452 B.c. Ltd.. The generic name of Eco Sanitizer Liquid is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: 0966452 B.c. Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Eco Sanitizer Liquid 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 80 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)

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: 0966452 B.c. Ltd.
Labeler Code: 80731
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: 10-08-2020 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.

Eco Sanitizer Liquid Product Label Images

Eco Sanitizer Liquid 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

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

Use: Hand sanitizer to help reduce bacteria on skin

Dosage & Administration

Directions for Use: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Otc - Active Ingredient

Medicinal Ingredients: Ethyl Alcohol* (80% v/v).

Inactive Ingredient

Ingredients: Aqua, Glycerin*, Hydrogen Peroxide*.

Warnings

Warning: For external use only. Flammable. Keep away from open flame and sources of heat. Avoid contact with eyes. Should this occur, flush eyes with water. If irritation develops, discontinue use and contact a health care practitioner.Contraindications: Do not use on children/infants less than 2 years of age (unless directed by a health care practitioner).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Storage And Handling

Store between 15° C/59° F and 30° C/86° F

* Please review the disclaimer below.