NDC 43116-004 Shierjie Disinfecting Soft Wipes Antibacterial

Shierjie Disinfecting Soft Wipes Antibacterial

NDC Product Code 43116-004

NDC CODE: 43116-004

Proprietary Name: Shierjie Disinfecting Soft Wipes Antibacterial 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: Shierjie Disinfecting Soft Wipes Antibacterial 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

  • 43116 - Shenzhen Shierjie Biological Engineering Co., Ltd
    • 43116-004 - Shierjie Disinfecting Soft Wipes Antibacterial

NDC 43116-004-02

Package Description: 10 CLOTH in 1 BAG

NDC Product Information

Shierjie Disinfecting Soft Wipes Antibacterial with NDC 43116-004 is a a human over the counter drug product labeled by Shenzhen Shierjie Biological Engineering Co., Ltd. The generic name of Shierjie Disinfecting Soft Wipes Antibacterial is shierjie disinfecting soft wipes antibacterial. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Shenzhen Shierjie Biological Engineering 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.

Shierjie Disinfecting Soft Wipes Antibacterial 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 .09 g/1001
  • DIDECYLDIMONIUM CHLORIDE .04 g/1001

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.

  • ALOE VERA FLOWER (UNII: 575DY8C1ER)
  • 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: Shenzhen Shierjie Biological Engineering Co., Ltd
Labeler Code: 43116
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.

Shierjie Disinfecting Soft Wipes Antibacterial Product Label Images

Shierjie Disinfecting Soft Wipes Antibacterial 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

Benzalkonium Chioride 0.1%, Chlorhexidine Diacetate 0.1%, Phenoxyethanol 0.02%

Purpose

Antimicrobial

Warnings

For external use only, please keep away from fire and children, store in a cool and dry place, avoid direct sunlight

Otc - Do Not Use

Do not use if you are allergic to any of the ingredient

Otc - When Using

Keep out of eyes. In contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs.

These may be signs of a serious condition

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

This product is mild in nature and not hurt the skin, without irritation.

Effectively kills E. coli and staphylococcus aureus in the skin of hands or skin mucous membranes and objects, with a killing rate of 99.9%.

Adults and children 2 years and over children2 years

Other Information

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Inactive Ingredients

Aloe Barbadensis extract, glycerin, Aqua non-woven

Indications & Usage

Use it after unpacking the product, It is used for disinfection and cleaning of human skin, and can also be used for cleaning and disinfecting surfaces

* Please review the disclaimer below.