NDC 78183-006 Antibacterial Wet Wipes

0.13% Benzalkonium Chloride

NDC Product Code 78183-006

NDC 78183-006-01

Package Description: 80 U in 1 BAG

NDC Product Information

Antibacterial Wet Wipes with NDC 78183-006 is a a human over the counter drug product labeled by Kunming Ansheng Industry & Trade Co., Ltd.. The generic name of Antibacterial Wet Wipes is 0.13% benzalkonium chloride. 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.

Antibacterial 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 .13 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)
  • ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: 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: 07-02-2020 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 Wet Wipes Product Label Images

Antibacterial 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(S)

Benzalkonium Chloride 0.13% v/v;

Purpose

Antibacterial; Kill 99% of germs that may cause illness in just 5 minutes;

Use

• For hand washing to decrease bacteria on the skin.

• Recommended for repeated use.

• Do not push fingers through opening.

Warnings

For external use only. Read the product label carefully before use.

Do Not Use

  • On infants less than 2 months of ageon open skin woundsIf you have hypersensitivity to any of the components of the formula, do not use the product.

Otc - When Using

When using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse immediately with plenty of water for several minuter;In case of ingestion, do not induce vomiting and consult a doctor immediately, taking the product container or label.

Otc - Stop Use

Stop usage if skin irritation occurs and consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children and pets.

Directions

Directions• After use, dispose the wipes in the trash. Do not flush in toilet.

• Always reseal the transparent seal securely between the uses to

Other Information

  • Keep containers tightly closed in a cool, dry place and well-ventilated place.Recommended Store temperature: 0℃ to 40℃Keep wipes inside the original packaging. Store unopened packages in a cool, dry place away from direct light inaccessible to small children.

Inactive Ingredients

Aqua, Ethanol, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20, Phenoxyethanol, Parfum

* Please review the disclaimer below.