NDC 63131-0004 Dermatize

Benzethonium Chloride

NDC Product Code 63131-0004

NDC 63131-0004-1

Package Description: 15140 JUG in 1 CASE > 3785 mL in 1 JUG

NDC Product Information

Dermatize with NDC 63131-0004 is a a human over the counter drug product labeled by Anderson Chemical Company. The generic name of Dermatize is benzethonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Anderson Chemical Company

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Dermatize 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.

  • HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
  • COCAMINE OXIDE (UNII: QWA2IZI6FI)
  • HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
  • UNDECETH-7 (UNII: R6B5PCO2JN)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)

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: Anderson Chemical Company
Labeler Code: 63131
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: 10-02-2020 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.

Dermatize Product Label Images

Dermatize 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, 0.2% w/v

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin.

Warning

For external use only.

When Using This Product

  • Discontinue use if irritatio and redness develop.do not use in or near eyes.

Stop Use And Ask A Doctor If

Stop use and ask a doctor if irritation or redness develops, or if conditions persist for more than 72 hours.

Keep Out Of Reach Of Children.

  • Keep out of reach of children, except under adult supervision.
  • In case of accidental ingestion, see medical attention or contact a poision control cernter immediately.

Directions

  • Hands need not be washed prior to using.For one step hand wash/antiseptic skin cleaning.Place 5 milliliters in palm of hand, add water, work up a lather and scrub for 30 seconds.Rinse hands thoroughly with potable water after washing.

Inactive Ingredients

Citric acid; 1,3-Dihydroxymethyl-5,5-dimethylhydantoin and 3-iodo-2-propynyl butyl carbamate; Ethoxylated C11 Alcohol; Hydrogenated starch hydrolysate; Hydroxypropyl methylcellulose; N-alkykl (C12-C16)-N, N-dimethylamine oxide; Sodium hydroxide; Water.

* Please review the disclaimer below.