Antibacterial Wet Wipes

Benzethonium Chloride


Tianjin Yansheng Industrial Trade Company
Human Otc Drug
NDC 70031-003
Antibacterial Wet Wipes also known as Benzethonium Chloride is a human otc drug labeled by 'Tianjin Yansheng Industrial Trade Company'. National Drug Code (NDC) number for Antibacterial Wet Wipes is 70031-003. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Antibacterial Wet Wipes drug includes Benzethonium Chloride - .115 g/100g . The currest status of Antibacterial Wet Wipes drug is Active.

Drug Information:

Drug NDC: 70031-003
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Antibacterial Wet Wipes
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Benzethonium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Tianjin Yansheng Industrial Trade Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Swab
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:BENZETHONIUM CHLORIDE - .115 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 10 Mar, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 15 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part333A
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1049374
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0639277241894
UPC stands for Universal Product Code.
UNII:PH41D05744
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
70031-003-011 POUCH in 1 PACKAGE (70031-003-01) / 3 g in 1 POUCH08 Jan, 2018N/ANo
70031-003-0210 POUCH in 1 PACKAGE (70031-003-02) / 3 g in 1 POUCH08 Jan, 2018N/ANo
70031-003-033 PACKAGE in 1 BAG (70031-003-03) / 10 POUCH in 1 PACKAGE / 3 g in 1 POUCH08 Jan, 2018N/ANo
70031-003-0420 PACKAGE in 1 BOX (70031-003-04) / 1 POUCH in 1 PACKAGE / 3 g in 1 POUCH08 Jan, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose antibacterial

Product Elements:

Antibacterial wet wipes benzethonium chloride potassium sorbate water quaternium-22 propylene glycol disodium edta-copper benzethonium chloride benzethonium citraconic acid alcohol tocopherol aloe vera leaf peg-60 castor oil

Indications and Usage:

Use decreases bacteria on skin

Warnings:

Warnings for external use only. do not use over large areas of the body if you are allergic to any of the ingredients.when using this product do not get into eyes.if contact occurs, rinse thoroughly with water.stop use and ask a doctor if irritation or rash develops and ontinues for more than 72 hours. 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.

Dosage and Administration:

Directions for adults and children of 2 years and over use on hands and face to clean and refresh, allow skin to air dry. for children under 2 years ask a doctor before use.

Package Label Principal Display Panel:

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Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.