NDC 61924-102 Hand-e-foam

Otc Antimicrobial Drug Products

NDC Product Code 61924-102

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

NDC Product Information

Hand-e-foam with NDC 61924-102 is a 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.

Labeler Name: Dermarite Industries, Llc

Dosage Form: Aerosol, 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.

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.

Hand-e-foam 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 .002 g/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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYETHYL CETYLDIMONIUM PHOSPHATE (UNII: 9G05UO431K)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PEG-8 RICINOLEATE (UNII: DM36F4D2OU)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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.

  • 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: Dermarite Industries, Llc
Labeler Code: 61924
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: 08-08-2002 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.

Hand-e-foam Product Label Images

Hand-e-foam 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 0.20%

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

* Please review the disclaimer below.