NDC 77324-001 Two-bin Dry Storage Professional Disinfectant Water Wipe

Benzalkonium Chloride

NDC Product Code 77324-001

NDC CODE: 77324-001

Proprietary Name: Two-bin Dry Storage Professional Disinfectant Water Wipe 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: Benzalkonium Chloride 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

  • 77324 - Zhejiang Zhongrun New Material Technology Co., Ltd.
    • 77324-001 - Two-bin Dry Storage Professional Disinfectant Water Wipe

NDC 77324-001-01

Package Description: 15 CONTAINER in 1 BOX > 6.3 g in 1 CONTAINER

NDC Product Information

Two-bin Dry Storage Professional Disinfectant Water Wipe with NDC 77324-001 is a a human over the counter drug product labeled by Zhejiang Zhongrun New Material Technology Co., Ltd.. The generic name of Two-bin Dry Storage Professional Disinfectant Water Wipe is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Zhejiang Zhongrun New Material Technology 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.

Two-bin Dry Storage Professional Disinfectant Water Wipe 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 .13 g/100g

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.

  • DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
  • WATER (UNII: 059QF0KO0R)

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 Zhongrun New Material Technology Co., Ltd.
Labeler Code: 77324
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: 05-04-2020 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.

Two-bin Dry Storage Professional Disinfectant Water Wipe Product Label Images

Two-bin Dry Storage Professional Disinfectant Water Wipe 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)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic

Use

Help protect skin (24 hours) and various object surfaces (28 days) and decrease the risk of infections of fungus, bacteria & virus

Warnings

For external use only.

Do Not Use

On children less than 2 years of age unless directed by a doctor.

When Using This Prodcut

Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use And Ask A Doctor

If condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

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.

Directions

  • Open methodology:Advise to use within TWO minutes after open. Otherwise it could be solidified.Do not wash before day.For use as antiseptic on object surfaces, adults and children 2 years of age or olderWipe the area and allow to dry.Apply to face, hands, body and object surfaces.Not available for conductive parts.

Other Information

  • Store at a shady, cool and dry place.It could freeze under 32F (0C) and be available after melting.

Inactive Ingredients

Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride), Water

* Please review the disclaimer below.