Sanivir Hands, Body, And Surfaces Sanitizer
Didecyldimonium Chloride And Benzalkonium Chloride Liquid
Kemix Quimica, S.a. De C.v.
Human Otc Drug
NDC 77396-001Sanivir Hands, Body, And Surfaces Sanitizer also known as Didecyldimonium Chloride And Benzalkonium Chloride Liquid is a human otc drug labeled by 'Kemix Quimica, S.a. De C.v.'. National Drug Code (NDC) number for Sanivir Hands, Body, And Surfaces Sanitizer is 77396-001. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sanivir Hands, Body, And Surfaces Sanitizer drug includes Benzalkonium Chloride - 1 mg/.001L Didecyldimonium Chloride - 2.5 mg/.001L . The currest status of Sanivir Hands, Body, And Surfaces Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 77396-001 |
| 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: | Sanivir Hands, Body, And Surfaces Sanitizer |
| 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: | Didecyldimonium Chloride And Benzalkonium Chloride Liquid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kemix Quimica, S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 mg/.001L
DIDECYLDIMONIUM CHLORIDE - 2.5 mg/.001L
|
| 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: | 07 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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: | Kemix Quimica, S.A. de C.V.
|
| 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
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 |
|---|
| 77396-001-01 | 1000 L in 1 CONTAINER (77396-001-01) | 12 Dec, 2020 | N/A | No |
| 77396-001-02 | 5 L in 1 BOTTLE, PLASTIC (77396-001-02) | 12 Dec, 2020 | N/A | No |
| 77396-001-03 | .075 L in 1 BOTTLE, PLASTIC (77396-001-03) | 12 Dec, 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 otc - purpose section otc - purpose section
Product Elements:
Sanivir hands, body, and surfaces sanitizer didecyldimonium chloride and benzalkonium chloride liquid triethanolamine tris(dihydrogen phosphate) alcohol didecyldimonium chloride didecyldimonium water isopropyl alcohol benzalkonium chloride benzalkonium glycerin sanivir gel plus hand sanitizer didecyldimonium chloride and benzalkonium chloride liquid trolamine alcohol isopropyl alcohol didecyldimonium chloride didecyldimonium water magnesium disodium edta benzalkonium chloride benzalkonium methyl alcohol glycerin
Indications and Usage:
Indications and usage indications and usage section indications and usage section
Warnings:
Warnings warnings warnings
Dosage and Administration:
Dosage and administration section sanivir
Package Label Principal Display Panel:
Sanivir hands, body, and surfaces sanitizer 1,000 lt (264 gallons) 77396-001-01 sanivir 1000
Sanivir hands, body, and surfaces sanitizer 5lt (1.32 gallons) 77396-001-02 sanivir 5
Sanivir hands, body, and surfaces sanitizer 75ml (2.4fl.oz) ndc: 77396-01-003 sanivir 75
Sanivir gel plus sanitizer 75ml (2.4fl.oz) ndc: 77396-002-02 sanivir gel plus 75
Sanivir gel plus sanitizer 5lt (1.32gal) ndc: 77396-002-01 sanivir gel plus 5