Ecolab
Benzalkonium Chloride
Kay Chemical Company
Human Otc Drug
NDC 63146-122Ecolab also known as Benzalkonium Chloride is a human otc drug labeled by 'Kay Chemical Company'. National Drug Code (NDC) number for Ecolab is 63146-122. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Ecolab drug includes Benzalkonium Chloride - 19.8 mg/mL . The currest status of Ecolab drug is Active.
Drug Information:
| Drug NDC: | 63146-122 |
| 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: | Ecolab |
| 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kay Chemical Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - 19.8 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: | 18 Feb, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | 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: | 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: | Kay Chemical Company
|
| 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 |
|---|
| 63146-122-11 | 2000 mL in 1 BOTTLE, PLASTIC (63146-122-11) | 18 Feb, 2016 | 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:
Ecolab benzalkonium chloride benzalkonium chloride benzalkonium water lauramine oxide cocamidopropyl propylene glycol-dimonium chloride phosphate glycerin polyquaternium-7 (70/30 acrylamide/dadmac; 1600 kd) hexylene glycol methyl gluceth-20 peg-7 glyceryl cocoate edetate disodium lactic acid methylchloroisothiazolinone peg-12 dimethicone glycereth-18 ethylhexanoate d&c red no. 33
Indications and Usage:
Uses for handwashing to decrease bacteria on the skin
Warnings:
Warnings for external use only do not use in eyes when using this product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only do not use in eyes when using this product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours 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 if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop
Dosage and Administration:
Directions: concentrated solution do not mix with anything except for potable water use only provided bottles for diution and dispensing of ready-to-use product insert probe into bag, twist cap tight, and close dispenser fill hand soap bottle with solution from dispenser place bottle into a nexa dispenser for use directions: ready-to-use solution wet hands with warm water apply soap to hands and scrub vigorously wash between fingers, around fingernails, and back of hands rinse hands thoroughly with warm water dry hands with clean towel or with mechanical dryer
Package Label Principal Display Panel:
Principal display panel and representative label ecolab ® ndc 63146-122-11 concentrated foaming antibacterial hand soap for institutional use only distributed by | distribuido por: kay chemical company · 8300 capital drive greensboro nc 27409-9790 usa customer service: (800) 529-5458 ©2016 kay chemical company all rights reserved | todas los derechos reservados made in usa | hecho en estados unidos 763845-00 kusa 7+3845/8000/0116 net contents: 2l (0.53 us gal) representative label
Further Questions:
Questions? call 1-800-529-5458