NDC 61924-102 Hand-e-foam
Otc Antimicrobial Drug Products Aerosol, Foam Topical

Product Information

Hand-e-foam is a human over the counter drug product labeled by Dermarite Industries, Llc. The generic name of Hand-e-foam is otc antimicrobial drug products. The product's dosage form is aerosol, foam and is administered via topical form.

Product Code61924-102
Proprietary Name 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.
Hand-e-foam
Non-Proprietary Name 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.
Otc Antimicrobial Drug Products
Product Type 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.
Human Otc Drug
Dosage FormAerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
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.
Dermarite Industries, Llc
Labeler Code61924
FDA Application Number 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.
part333A
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-08-2002
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Hand-e-foam?


Product Packages

NDC 61924-102-08

Package Description: 237 mL in 1 BOTTLE, PUMP

NDC 61924-102-17

Package Description: 50 mL in 1 BOTTLE, PUMP

NDC 61924-102-34

Package Description: 1000 mL in 1 CARTRIDGE

Product Details

What are Hand-e-foam Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BENZETHONIUM CHLORIDE .002 g/mL - Bactericidal cationic quaternary ammonium surfactant used as a topical anti-infective agent. It is an ingredient in medicaments, deodorants, mouthwashes, etc., and is used to disinfect apparatus, etc., in the food processing and pharmaceutical industries, in surgery, and also as a preservative. The compound is toxic orally as a result of neuromuscular blockade.

Hand-e-foam Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Hand-e-foam Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Hand-e-foam Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient:



Benzethonium Chloride 0.20%


Purpose:



Antiseptic Handwash


Uses:



  • Hand sanitizer: Helps reduce bacteria on skin that could cause disease. Recommended for repeated use.
  • First aid to help protect against skin infection in minor cuts, scrapes, burns.

Warnings:



  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • When using this product do not apply to large area of raw or blistered skin in large quantities; do not use in or near the eyes. 
  • Ask a doctor before use if you have , deep of puncture wounds, animal bites, serious burns


Warnings



  • Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:



  • Hand sanitizer: Wet hands thoroughly with product and allow to dry without wiping. Children should be supervised when using this product.
  • First Aid: Clean the affected area whenever possible. Apply to affected area not more than 3 to 4 times daily. May be covered with a sterile bandage:if bandaged, let dry first.

Other Information:



Store at room temperature (59°-86°F)


Inactive Ingredients:



Benzalkonium Chloride, Cetrimonium Chloride, Diazolidinyl Urea, Fragrance, Glycerin, Hydroxethyl Cetyldimonium Phosphate, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, PEG-40 Dimethicone, PEG-40 Hydrogenated Castor Oil, PEG-8 Ricinoleate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Tocopheryl Acetate, Water


Hand-E-Foam Package Label Principal Display Panel




* Please review the disclaimer below.