NDC 75543-201 Antibacterial Wipes

Antibacterial Wipes

NDC Product Code 75543-201

NDC 75543-201-18

Package Description: 100 PATCH in 1 PACKAGE > 1 U in 1 PATCH (75543-201-01)

NDC Product Information

Antibacterial Wipes with NDC 75543-201 is a a human over the counter drug product labeled by Fujian Yifa Healthcare Products Co., Ltd.. The generic name of Antibacterial Wipes is antibacterial wipes. The product's dosage form is patch and is administered via topical form.

Labeler Name: Fujian Yifa Healthcare Products Co., Ltd.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Antibacterial 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 .15 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Fujian Yifa Healthcare Products Co., Ltd.
Labeler Code: 75543
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: 05-05-2020 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.

Antibacterial Wipes Product Label Images

Antibacterial 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

Benzalkonium Chloride, 0.15% w/w; Didecyldimonium Chloride, 0.2% w/w.

Inactive Ingredient

Phenoxyethanol, Propylene Glycol, Glycerin, Water.

Purpose

Kill germs of staphylococcus aureus, candida albicans and escherichia coli.

When Using

Antibacterial for hands, medical devices, medical supplies and the surface of articles.

Do Not Use

  • On children less than 2 months of ageon open skin wounds

Stop Use

Stop to use immediately if having a negative impact on the objects and flush with water.

Keep Out Of Reach Of Children

Keep out of reach of children.

Indications & Usage

Skin’s cleaning care, Article surface’s cleaning and maintenance. Remove seal, pull out sheet and wipe skin or articles.(For external use only)

Dosage & Administration

Use it as needed, after following the usage instructions. For external use only.

Warnings

  • Discard immediately after use, and cover the lid in time. Follow the principle” One wipe to one article” to avoid cross-infection. Avoid contact with eyes. If contact occurs, immediately flush with water. External use Prohibit internal use. Be sure to wear gloves when having hand cut or be allergic to wipes.

* Please review the disclaimer below.