NDC 77573-009 Charm Tex 3 In 1 Antibacterial Shave Gel Body Wash

Benzethonium Chloride

NDC Product Code 77573-009

NDC CODE: 77573-009

Proprietary Name: Charm Tex 3 In 1 Antibacterial Shave Gel Body Wash What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzethonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 77573-009-01

Package Description: 57 g in 1 BOTTLE

NDC 77573-009-02

Package Description: 118 g in 1 BOTTLE

NDC 77573-009-03

Package Description: 236 g in 1 BOTTLE

NDC Product Information

Charm Tex 3 In 1 Antibacterial Shave Gel Body Wash with NDC 77573-009 is a a human over the counter drug product labeled by Jiangsu Aimeili Cosmetic Co.,ltd.. The generic name of Charm Tex 3 In 1 Antibacterial Shave Gel Body Wash is benzethonium chloride. The product's dosage form is lotion/shampoo and is administered via topical form.

Labeler Name: Jiangsu Aimeili Cosmetic Co.,ltd.

Dosage Form: Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents.

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 3 In 1 Antibacterial Shave Gel Body Wash 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.

  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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.

Product Labeler Information

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

Labeler Name: Jiangsu Aimeili Cosmetic Co.,ltd.
Labeler Code: 77573
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: 03-14-2021 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: 12-31-2022 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 - NO 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 3 In 1 Antibacterial Shave Gel Body Wash Product Label Images

Charm Tex 3 In 1 Antibacterial Shave Gel Body Wash 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

Benzethonium Chloride 0.1%

Purpose

Antiseptic

Use

As shaving gel: Smooth skin when do shaving and help reduce bacteriaAs body wash: Body cleaning to help reduce bacteriaAs shampoo: Hair cleaning to help reduce bacteria

Warnings

For external use only

Otc - Stop Use

Keep out of eyes, ears, and mouth. In case of eye contact, flush eyes with waterStop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours

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

As shave gel: Wet skin and squeeze gel onto figer tips. Spread gel evenly on skin and shaveAs body wash: Squeeze body wash onto wet hand or wash cloth.  Apply, lather, and rinse.As shampoo: Wet hair, apply shampoo, work up a rich lather and rinse

Inactive Ingredients

Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide Dea, Sodium Chloride, DMDM Hydantoin, Fragrance, Citric Acid

* Please review the disclaimer below.