Kleanmann - Hand Sanitizer And Surface Disinfectant
Bac (benzalkonium Chloride), Ddac (didecyldimonium Chloride)
Lamer Group Llc
Human Otc Drug
NDC 80472-001Kleanmann - Hand Sanitizer And Surface Disinfectant also known as Bac (benzalkonium Chloride), Ddac (didecyldimonium Chloride) is a human otc drug labeled by 'Lamer Group Llc'. National Drug Code (NDC) number for Kleanmann - Hand Sanitizer And Surface Disinfectant is 80472-001. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Kleanmann - Hand Sanitizer And Surface Disinfectant drug includes Benzalkonium Chloride - 1.91 g/120mL Didecyldimonium Chloride - .47 g/120mL . The currest status of Kleanmann - Hand Sanitizer And Surface Disinfectant drug is Active.
Drug Information:
| Drug NDC: | 80472-001 |
| 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: | Kleanmann - Hand Sanitizer And Surface Disinfectant |
| 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: | Bac (benzalkonium Chloride), Ddac (didecyldimonium Chloride) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lamer Group Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | BENZALKONIUM CHLORIDE - 1.91 g/120mL
DIDECYLDIMONIUM CHLORIDE - .47 g/120mL
|
| 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: | 01 Oct, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | Lamer Group LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0759687669405
|
| UPC stands for Universal Product Code. |
| UNII: | F5UM2KM3W7
JXN40O9Y9B
|
| 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 |
|---|
| 80472-001-01 | 120 mL in 1 BOTTLE, SPRAY (80472-001-01) | 01 Oct, 2020 | 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, hand sanitizer spray and surface disinfectant
Product Elements:
Kleanmann - hand sanitizer and surface disinfectant bac (benzalkonium chloride), ddac (didecyldimonium chloride) water benzalkonium chloride benzalkonium didecyldimonium chloride didecyldimonium
Indications and Usage:
Use for hand and surface sanitizing to decrease harmful bacteria and viruses on the skin or frequently touched objects. recommended for repeated use.
Warnings:
Warnings
Do Not Use:
Warnings
Dosage and Administration:
Directions for hand disinfection, rub the solution carefully into your palms for 30 seconds. clean and disinfect frequently touched objects and surfaces by spraying directly on them.
Stop Use:
Stop use and contact a doctor if redness or irritation develops and persists for more than 72 hours.
Package Label Principal Display Panel:
Package label - principal display panel 120 ml ndc: 00000-000-00 120ml label