NDC 78453-001 (badiful) Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 78453-001

NDC 78453-001-01

Package Description: .02 mL in 1 BAG

NDC 78453-001-02

Package Description: .2 mL in 1 BAG

NDC 78453-001-03

Package Description: .4 mL in 1 BAG

NDC 78453-001-04

Package Description: .6 mL in 1 BAG

NDC 78453-001-05

Package Description: 1 mL in 1 BAG

NDC 78453-001-06

Package Description: 1.14 mL in 1 BAG

NDC 78453-001-07

Package Description: 1.48 mL in 1 BAG

NDC 78453-001-08

Package Description: 1.9 mL in 1 BOX

NDC Product Information

(badiful) Antibacterial Wipes with NDC 78453-001 is a a human over the counter drug product labeled by Zhangzhou Kangbei Hygienic Products Co., Ltd.. The generic name of (badiful) Antibacterial Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Zhangzhou Kangbei Hygienic Products Co., Ltd.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

(badiful) 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 13 mg/100mL
  • CETYLPYRIDINIUM CHLORIDE 5 mg/100mL
  • PROPYLENE GLYCOL 2 mg/100mL
  • CHLORPHENESIN 2 mg/100mL

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)

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: Zhangzhou Kangbei Hygienic Products Co., Ltd.
Labeler Code: 78453
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-31-2020 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.

(badiful) Antibacterial Wipes Product Label Images

(badiful) 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

Otc - Active Ingredient

Benzalkonium Chloride

Cetylpridnium Chloride

Propylene Glycol

Chlorphenesin
Purpose: Antiseptic

Otc - Do Not Use

In children less than 2 months of age - on open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

How To Use

Wipe the body skin or other surface

Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive Ingredients

Water

Indications & Usage

Wipe the body skin or other surface

Supervise children under 6 years of age when using this product to avoid swallowing.

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.

Otc - Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

* Please review the disclaimer below.