NDC 78293-008 Cleansing Disinfection Wipes

Cleansing Disinfection Wipes

NDC Product Code 78293-008

NDC 78293-008-01

Package Description: 8 CLOTH in 1 BAG

NDC 78293-008-02

Package Description: 10 CLOTH in 1 BAG

NDC 78293-008-03

Package Description: 30 CLOTH in 1 BAG

NDC 78293-008-04

Package Description: 50 CLOTH in 1 BAG

NDC 78293-008-05

Package Description: 80 CLOTH in 1 BAG

NDC 78293-008-06

Package Description: 100 CLOTH in 1 BAG

NDC Product Information

Cleansing Disinfection Wipes with NDC 78293-008 is a a human over the counter drug product labeled by Guangdong Bolicen Bio-technology Co., Ltd.. The generic name of Cleansing Disinfection Wipes is cleansing disinfection wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Guangdong Bolicen Bio-technology 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.

Cleansing Disinfection 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 .1 1/1001
  • POLIHEXANIDE .05 1/1001
  • ALCOHOL 10 1/1001
  • DIDECYLDIMONIUM CHLORIDE .3 1/1001

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: Guangdong Bolicen Bio-technology Co., Ltd.
Labeler Code: 78293
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: 07-12-2020 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.

Cleansing Disinfection Wipes Product Label Images

Cleansing Disinfection 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)

Alcohol 10% w/w Benzalkonium Chlorid 0. 1%w/w Poly( hexamethylenebiguanide )hydro-chloride 0.05%w/wDidecyl Dimethylammonium Chloride 0.3%w/w

Purpose

Antiseptic

Use

USE FOR HAND AND SKIN SURFACE DISINFECTING AND CLEANSING

Warnings

For extemal use only. Keep away from sunlight, store in a cool, dry place

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 and sore or broken skin, If contact with eyes occurs, rinse thoroughly with water.top use and ask a doctor if irritation or rash occurs, These may be signs of a serious condition Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

Directions

Open lid, For first time user, remove tamper evident seal, Pullout wipes as needed. Close the lid after use each time top revent moisture loss

Other Information

Do not store above 40 °C. May discolor some fabrics and surfaces

Store between15-30°C

Inactive Ingredients

Water

* Please review the disclaimer below.