NDC 42003-101 Disinfection Wet Wipes

Disinfection Wet Wipes

NDC Product Code 42003-101

NDC 42003-101-80

Package Description: 80 U in 1 PACKAGE

NDC Product Information

Disinfection Wet Wipes with NDC 42003-101 is a a human over the counter drug product labeled by Zhejiang Jiayan Daily Commodity Co., Ltd. The generic name of Disinfection Wet Wipes is disinfection wet wipes. The product's dosage form is patch and is administered via topical form.

Labeler Name: Zhejiang Jiayan Daily Commodity 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.

Disinfection Wet 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
  • PHENOXYETHANOL .5 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)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • 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 Jiayan Daily Commodity Co., Ltd
Labeler Code: 42003
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: 05-07-2020 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.

Disinfection Wet Wipes Product Label Images

Disinfection Wet 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

Phenoxyethanol, 0.5% w/w; Benzalkonium Chloride, 0.15% w/w.

Inactive Ingredient

Ethylhexylglycerin; Didecyldimonium Chloride; Propylene Glycol; Glycerin; Water.

Purpose

Kill the intestinal pathogenic bacterium, staphylococcus aureus pseudomonas aeruginosa candida albicans.

When Using

Please close the pakage immediately after use. If there are obvious stains on the surface of the object, when the blood stains, should use a piece of wet towel to remove the dirty, and then take a piece of wet towel for sterilization treatment.

Do Not Use

For external use, avoid contact with eyes and wound skin.

Stop Use

If you feel uncomfortable, please seek medical advice.

Keep Out Of Reach Of Children

The product should be kept out of reach of children.

Indications & Usage

Applicable to the hand skin, object surface and medical equipment surface cleaning sterilization.

Dosage & Administration

Open the package of wet towel and take out and unfold the wet towel. From one side of the surface of the object, from the top down by the s-type wipe to the entire surface, action for 3 minutes.

Warnings

For external use, avoid contact with eyes and wound skin. This product is disposable, should follow the "one thing one towel" use principle, avoid cross contamination.

Other Information

Keep out of the light, sealed, and in a cool place.

* Please review the disclaimer below.