Defense Zone Antibacterial
Benzalkonium Chloride
Prime Enterprises, Inc.
Human Otc Drug
NDC 58443-0379Defense Zone Antibacterial also known as Benzalkonium Chloride is a human otc drug labeled by 'Prime Enterprises, Inc.'. National Drug Code (NDC) number for Defense Zone Antibacterial is 58443-0379. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Defense Zone Antibacterial drug includes Benzalkonium Chloride - 1.287 mg/mL . The currest status of Defense Zone Antibacterial drug is Active.
Drug Information:
| Drug NDC: | 58443-0379 |
| 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: | Defense Zone Antibacterial |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Defense Zone |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Antibacterial |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Prime Enterprises, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Soap |
| 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 - 1.287 mg/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: | 04 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | part333E |
| 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: | 05 May, 2026 |
| 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: | Prime Enterprises, Inc.
|
| 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. |
| UNII: | F5UM2KM3W7
|
| 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 |
|---|
| 58443-0379-5 | 251 mL in 1 BOTTLE, PUMP (58443-0379-5) | 04 Dec, 2020 | 31 Dec, 2023 | 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
Product Elements:
Defense zone antibacterial benzalkonium chloride benzalkonium chloride benzalkonium peg-150 distearate glycerin aloe vera leaf cetrimonium chloride citric acid monohydrate coco diisopropanolamide ethylhexylglycerin lauramine oxide phenoxyethanol fd&c red no. 40 tetrasodium glutamate diacetate camellia oleifera leaf water fd&c yellow no. 5 peach
Indications and Usage:
Use for handwashing to decrease bacteria on the skin
Warnings:
Warnings for external use only. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if irritation and redness develop keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions wet hands, work into a rich lather rinse well for children under 6, use only under adult supervision
Stop Use:
Stop use and ask a doctor if irritation and redness develop
Package Label Principal Display Panel:
Defense zone antibacterial hand soap fresh peach principal display label