Hand-e-foam
Otc Antimicrobial Drug Products
Dermarite Industries, Llc
Human Otc Drug
NDC 61924-102Hand-e-foam also known as Otc Antimicrobial Drug Products is a human otc drug labeled by 'Dermarite Industries, Llc'. National Drug Code (NDC) number for Hand-e-foam is 61924-102. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Hand-e-foam drug includes Benzethonium Chloride - .002 g/mL . The currest status of Hand-e-foam drug is Active.
Drug Information:
| Drug NDC: | 61924-102 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hand-e-foam |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Otc Antimicrobial Drug Products |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermarite Industries, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Foam |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | BENZETHONIUM CHLORIDE - .002 g/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 08 Aug, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333A |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | DermaRite Industries, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1041869
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0714196109347
0714196102027
|
| UPC stands for Universal Product Code. |
| UNII: | PH41D05744
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61924-102-08 | 237 mL in 1 BOTTLE, PUMP (61924-102-08) | 08 Aug, 2002 | N/A | No |
| 61924-102-17 | 50 mL in 1 BOTTLE, PUMP (61924-102-17) | 08 Aug, 2002 | N/A | No |
| 61924-102-34 | 1000 mL in 1 CARTRIDGE (61924-102-34) | 08 Aug, 2002 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose: antiseptic handwash
Product Elements:
Hand-e-foam otc antimicrobial drug products benzalkonium chloride cetrimonium chloride diazolidinyl urea glycerin hydroxyethyl cetyldimonium phosphate methylchloroisothiazolinone methylisothiazolinone methylparaben peg-8 dimethicone polyoxyl 40 hydrogenated castor oil peg-8 ricinoleate propylene glycol propylparaben sodium hydroxide .alpha.-tocopherol acetate water benzethonium chloride benzethonium
Indications and Usage:
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:
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
Dosage and Administration:
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.
Package Label Principal Display Panel:
Hand-e-foam package label principal display panel handefoam 34oz bottle and case labels.jpg handefoam 1pt7 and 8oz bottle and case labels