NDC 79794-600 Biopure Antibacterial Hand Wipe Unscented (1400 Ct)

Biopure Antibacterial Hand Wipe Unscented

NDC Product Code 79794-600

NDC CODE: 79794-600

Proprietary Name: Biopure Antibacterial Hand Wipe Unscented (1400 Ct) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Biopure Antibacterial Hand Wipe Unscented What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 79794 - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
    • 79794-600 - Biopure Antibacterial Hand Wipe Unscented (1400 Ct)

NDC 79794-600-01

Package Description: 1400 CLOTH in 1 PACKAGE

NDC Product Information

Biopure Antibacterial Hand Wipe Unscented (1400 Ct) with NDC 79794-600 is a a human over the counter drug product labeled by Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.. The generic name of Biopure Antibacterial Hand Wipe Unscented (1400 Ct) is biopure antibacterial hand wipe unscented. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Biopure Antibacterial Hand Wipe Unscented (1400 Ct) 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.

  • BENZALKONIUM CHLORIDE 12 1/1001

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: Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Labeler Code: 79794
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: 10-20-2020 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.

Biopure Antibacterial Hand Wipe Unscented (1400 Ct) Product Label Images

Biopure Antibacterial Hand Wipe Unscented (1400 Ct) 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 - Active Ingredient

Ethyl Alcohol 75%………………Antisepetic

Inactive Ingredient

Purified Water USP

Warnings

For external use only. Flammable. Keep away from heat or flame.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Do Not Use

Do not use in children less than 2 months of age.Do not use on open wounds.

Dosage & Administration

Apply to hands, allow to air dry without wipping.Discard wipe in trash receptable after use.Do not flush.

Otc - Purpose

To help reduce bacteria that potentially cause disease.

Indications & Usage

To help reduce bacteria that potentially cause disease

* Please review the disclaimer below.