NDC 78183-012 Vir-u-clean Disinfectant Cleaning Wipes

0.2% Quaternary Ammonium Salt

NDC Product Code 78183-012

NDC CODE: 78183-012

Proprietary Name: Vir-u-clean Disinfectant Cleaning Wipes 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: 0.2% Quaternary Ammonium Salt 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

  • 78183 - Kunming Ansheng Industry & Trade Co., Ltd.
    • 78183-012 - Vir-u-clean Disinfectant Cleaning Wipes

NDC 78183-012-01

Package Description: 25 U in 1 BAG

NDC Product Information

Vir-u-clean Disinfectant Cleaning Wipes with NDC 78183-012 is a a human over the counter drug product labeled by Kunming Ansheng Industry & Trade Co., Ltd.. The generic name of Vir-u-clean Disinfectant Cleaning Wipes is 0.2% quaternary ammonium salt. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kunming Ansheng Industry & Trade 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.

Vir-u-clean Disinfectant Cleaning Wipes 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 .1 U/100U
  • DIDECYLDIMONIUM CHLORIDE .2 U/100U

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)
  • 2-ETHYLHEXYL GLYCIDYL ETHER (UNII: LU1UZ98B89)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kunming Ansheng Industry & Trade Co., Ltd.
Labeler Code: 78183
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: 12-21-2020 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.

Vir-u-clean Disinfectant Cleaning Wipes Product Label Images

Vir-u-clean Disinfectant Cleaning Wipes 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)

Quaternary ammonium salt 0.2% v/v.

Purpose

To reduce bacteria for objects surface except human skin.

Use

THIS IS NOT A HAND WIPE, IT IS A DISINFECTING CLEANING WIPE.

Warnings

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

Do Not Use

  • Not for use on skin.Do not use on children less than 2 months of age.

Otc - Stop Use

If irritation or rash appears and lasts, stop using and consult a doctor.

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

  • Lift resealable sticker to pull individual wipes out.Reseal package when not using to prevent wipes from drying out.

Inactive Ingredients

Glycerol, Ethylhexyl glycerin, Pure water

Other Information

  • Dispose of wipe in the proper container after use.Do not flush down the toilet.Product Features: Contains disinfectant ingredients to kill 99.99% of common germs like staphylococcus aureus, escherichia coli,
  • Candida albicans, etc.

* Please review the disclaimer below.