NDC 61619-104 Antimicrobial Cleansing Gel

Benzethonium Chloride

NDC Product Code 61619-104

NDC 61619-104-01

Package Description: 29.57 mL in 1 BOTTLE, PLASTIC

NDC 61619-104-04

Package Description: 118.29 mL in 1 BOTTLE, PLASTIC

NDC 61619-104-08

Package Description: 236.59 mL in 1 BOTTLE, PLASTIC

NDC 61619-104-32

Package Description: 946.35 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antimicrobial Cleansing Gel with NDC 61619-104 is a a human over the counter drug product labeled by A-cute Derm, Incorporated. The generic name of Antimicrobial Cleansing Gel is benzethonium chloride. The product's dosage form is lotion and is administered via cutaneous form.

Labeler Name: A-cute Derm, Incorporated

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Antimicrobial Cleansing Gel 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 2 mg/mL

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.

  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • PEG-4 LAURATE (UNII: AYF4VM3N1Z)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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.

  • Cutaneous - Administration to the skin.
  • 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: A-cute Derm, Incorporated
Labeler Code: 61619
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: 02-20-2020 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.

Antimicrobial Cleansing Gel Product Label Images

Antimicrobial Cleansing Gel 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

Drug Facts

Kills 99.9% of harmful germs in 30 seconds.

Active Ingredients

Benzethonium Chloride (0.2%)

Inactive Ingredients

Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate.

Purpose

Antimicrobial Wash

Uses

•B-KLEER™ is a unique, non-drying cleanser. •Use on all skin types. •pH balanced. •May be used as a topical antimicrobial to help protect against skin infection.

Warnings

•External use only. •Do not use in eyes. •In case of deep wounds or puncture wounds, consult a physician. •If irritation develops and persists for more than a few days, discontinue use and consult a physician.

Directions

•Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean.

Other Information

•Alcohol Free •Moisturizes •Made in USA

* Please review the disclaimer below.