NDC 73343-001 Charm-tex Antibacterial

Benzethonium Chloride

NDC Product Code 73343-001

NDC 73343-001-01

Package Description: 1 APPLICATOR in 1 CASE > 14 g in 1 APPLICATOR

NDC 73343-001-02

Package Description: 1 APPLICATOR in 1 CASE > 43 g in 1 APPLICATOR

NDC 73343-001-03

Package Description: 1 APPLICATOR in 1 CASE > 85 g in 1 APPLICATOR

NDC Product Information

Charm-tex Antibacterial with NDC 73343-001 is a a human over the counter drug product labeled by Yangzhou Tracey Daily Chemical Plastic Co., Ltd.. The generic name of Charm-tex Antibacterial is benzethonium chloride. The product's dosage form is soap and is administered via cutaneous form.

Labeler Name: Yangzhou Tracey Daily Chemical Plastic Co., Ltd.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Charm-tex Antibacterial 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.

  • BENZETHONIUM CHLORIDE .1 g/100g

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.

  • SODIUM PALMATE (UNII: S0A6004K3Z)
  • COCONUT ACID (UNII: 40U37V505D)
  • PALM ACID (UNII: B6G0Y5Z616)
  • SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Yangzhou Tracey Daily Chemical Plastic Co., Ltd.
Labeler Code: 73343
FDA Application Number: part333E 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: 09-10-2019 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: 12-31-2020 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.

Charm-tex Antibacterial Product Label Images

Charm-tex Antibacterial 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

Other

Drug Facts

Active Ingredient

Benzethonium Chloride 0.1%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on skin.

Warnings

For External Use Only.

Otc - Do Not Use

Do not use this product on infants under 6.

Otc - When Using

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Otc - Stop Use

Stop use and ask doctor if irritation and redness develops.

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.

Directions

  • Wet bar with waterLather vigorously and wash skinRinse and dry thoroughly

Inactive Ingredients

Soap (Sodium Palmate and/or Sodiun Tallowate. Sodium Cocoate and/or Sodium Palm Kernelate) Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid,Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous.

* Please review the disclaimer below.