Stoko Refresh 4in1 Food Handler Foam
Triclosan
Deb Usa, Inc.
Human Otc Drug
NDC 11084-967Stoko Refresh 4in1 Food Handler Foam also known as Triclosan is a human otc drug labeled by 'Deb Usa, Inc.'. National Drug Code (NDC) number for Stoko Refresh 4in1 Food Handler Foam is 11084-967. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Stoko Refresh 4in1 Food Handler Foam drug includes Triclosan - .5 g/100mL . The currest status of Stoko Refresh 4in1 Food Handler Foam drug is Active.
Drug Information:
| Drug NDC: | 11084-967 |
| 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: | Stoko Refresh 4in1 Food Handler Foam |
| 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: | Triclosan |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Deb Usa, Inc. |
| 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: | TRICLOSAN - .5 g/100mL
|
| 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 Jun, 2014 |
| 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: | 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: | 23 Dec, 2025 |
| 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: | Deb USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 413247
|
| 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: | 4NM5039Y5X
|
| 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 |
|---|
| 11084-967-28 | 1000 mL in 1 BOTTLE, PLASTIC (11084-967-28) | 01 Jun, 2014 | 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 antimicrobial hand wash
Product Elements:
Stoko refresh 4in1 food handler foam triclosan triclosan triclosan water sodium cumenesulfonate sodium laureth sulfate propylene glycol cocamidopropyl betaine sodium benzoate anhydrous citric acid
Indications and Usage:
Uses cleanse harmful bacteria and dirt from the skin.
Warnings:
Warnings for external use only. if swallowed get medical help or contact a poison control center right away. should solution enter eyes, flush immediately with water. keep out of reach of children.
Dosage and Administration:
Directions place one pump in palm, add a little water and wash thoroughly. rinse hands after washing.
Package Label Principal Display Panel:
Stoko refresh® food handler foam ndc 11084-967-28 how to install: align bottle in to dispenser. press firmly into place until pump clicks. close cover. press dispenser to prime. to replace, push green tab up to release bottle. alinee la botella en el aplicador presionela firmemente en su lugar hasta que la bomba haga âclickâ. cierre la cubierta. presione el aplicador para cebar la bomba. para reemplazar, presione la prestana verde para liberar la botella. aligner la bouteille dans le distributeur lâinserer fermement en place jusquâa ce que la pompe emette un clic. fermer le couvercle. appuyer sur le distributeur pour render la pompe prete a distribuer le produit. pour remplacer, appuyer sur la languette verte afin de degager la bouteille. should solution enter the eyes, flush immediately with water. deb usa, inc. charlotte, nc 28217 phone + 1-800-248-7190 www.stokoskincare.com net contents: 1000 ml (33.82 fl.oz.) made in the usa stock #34974 food handler foam 34974 - 34656 - stoko refresh 4in1 fh foam 1l.jpg
Further Questions:
Questions? 800-334-0242 (mon-fri, 8am-5pm est)