Alcohol Free Foaming Hand Sanitizer
Benzalkonium Chloride
Betco Corporation, Ltd.
Human Otc Drug
NDC 65601-700Alcohol Free Foaming Hand Sanitizer also known as Benzalkonium Chloride is a human otc drug labeled by 'Betco Corporation, Ltd.'. National Drug Code (NDC) number for Alcohol Free Foaming Hand Sanitizer is 65601-700. This drug is available in dosage form of Soap. The names of the active, medicinal ingredients in Alcohol Free Foaming Hand Sanitizer drug includes Benzalkonium Chloride - 1.3 mg/mL . The currest status of Alcohol Free Foaming Hand Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 65601-700 |
| 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: | Alcohol Free Foaming Hand 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: | Benzalkonium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Betco Corporation, Ltd. |
| 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 - 1.3 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: | 12 Nov, 2012 |
| 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: | Betco Corporation, Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1020365
|
| 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. |
| 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 |
|---|
| 65601-700-04 | 3780 mL in 1 BOTTLE, PLASTIC (65601-700-04) | 01 Jan, 2016 | N/A | No |
| 65601-700-29 | 1000 mL in 1 BAG (65601-700-29) | 01 Jan, 2016 | N/A | No |
| 65601-700-53 | 50 mL in 1 BOTTLE, PUMP (65601-700-53) | 01 Jan, 2016 | N/A | No |
| 65601-700-55 | 207900 mL in 1 DRUM (65601-700-55) | 01 Jan, 2016 | N/A | No |
| 65601-700-88 | 500 mL in 1 BOTTLE, PUMP (65601-700-88) | 12 Nov, 2012 | 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:
Alcohol free foaming hand sanitizer purpose antiseptic
Product Elements:
Alcohol free foaming hand sanitizer benzalkonium chloride grapefruit oil butylphenyl methylpropional magnesium nitrate .beta.-citronellol, (+/-)- methylchloroisothiazolinone cyclomethicone 4 acetaldehyde geraniol hexamethylindanopyran dihydromyrcenol methyl dihydrojasmonate (synthetic) myrcene sodium pidolate isopropyl alcohol n-alkyl dimethyl benzyl ammonium chloride (c12-c18) linalool, (+/-)- orange oil d&c green no. 5 peg/ppg-15/15 allyl ether acetate hexyl salicylate alcohol lime oil methylisothiazolinone water benzalkonium chloride benzalkonium dioxane peg-6 cocamide lemon oil
Indications and Usage:
Alcohol free foaming hand sanitizer uses hand sanitizer to remove microorganisms on the skin. use this product when soap and water are not available.
Warnings:
Alcohol free foaming hand sanitizer warnings for external use only. avoid contact with eyes. if contact occurs, rinse thoroughly with water. discontinue use is irritation or redness develops. if irritation persists for more than 72 hours, consult a physician. keep out of reach of children . if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Alcohol free foaming hand sanitizer directions âread the entire label before using this product. âdispense 2 pumps of product onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
Package Label Principal Display Panel:
Alcohol free foaming hand sanitizer 53 29 88 04 55
Further Questions:
Alcohol free foaming hand sanitizer questions or comments? phone: (800) 777-9343 mds information: â(800) 891-4965