Extra Stength Hand Sanitizer Zytec Germ Buster
Alcohol 80%w/w
Empack Spraytech Inc.
Human Otc Drug
NDC 50021-008Extra Stength Hand Sanitizer Zytec Germ Buster also known as Alcohol 80%w/w is a human otc drug labeled by 'Empack Spraytech Inc.'. National Drug Code (NDC) number for Extra Stength Hand Sanitizer Zytec Germ Buster is 50021-008. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Extra Stength Hand Sanitizer Zytec Germ Buster drug includes Alcohol - 80 g/100g . The currest status of Extra Stength Hand Sanitizer Zytec Germ Buster drug is Active.
Drug Information:
| Drug NDC: | 50021-008 |
| 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: | Extra Stength Hand Sanitizer Zytec Germ Buster |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Extra Stength Hand Sanitizer |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Zytec Germ Buster |
| 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: | Alcohol 80%w/w |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Empack Spraytech Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Spray |
| 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: | ALCOHOL - 80 g/100g
|
| 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: | 08 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | Empack Spraytech Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1241663
|
| 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: | 3K9958V90M
|
| 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 |
|---|
| 50021-008-01 | 51 g in 1 CAN (50021-008-01) | 08 Apr, 2020 | N/A | No |
| 50021-008-02 | 100 g in 1 CAN (50021-008-02) | 08 Apr, 2020 | N/A | No |
| 50021-008-03 | 125 g in 1 CAN (50021-008-03) | 08 Apr, 2020 | N/A | No |
| 50021-008-04 | 200 g in 1 CAN (50021-008-04) | 08 Apr, 2020 | N/A | No |
| 50021-008-05 | 253 g in 1 CAN (50021-008-05) | 08 Apr, 2020 | N/A | No |
| 50021-008-06 | 400 g in 1 CAN (50021-008-06) | 08 Apr, 2020 | N/A | No |
| 50021-008-07 | 70 g in 1 CAN (50021-008-07) | 15 Apr, 2020 | N/A | No |
| 50021-008-08 | 352 g in 1 CAN (50021-008-08) | 15 Apr, 2020 | N/A | No |
| 50021-008-09 | 176 g in 1 CAN (50021-008-09) | 15 Apr, 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 antiseptic
Product Elements:
Extra stength hand sanitizer zytec germ buster alcohol 80%w/w alcohol alcohol water lime (citrus) isobutane
Indications and Usage:
Uses hand sanitizer to help reduces bacteria that potentially can cause disease. recommended for repeated use. for use when soap and water are not available
Warnings:
Warnings for external use only. flammable. keep away from fire or flame do not use in children less than 2 months age on open skin wounds stop use and ask a doctor if rash occurs. when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water 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. flammable. keep away from fire or flame do not use in children less than 2 months age on open skin wounds stop use and ask a doctor if rash occurs. when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water 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 keep out of eyes, ears, and mouth. in case of contact with eyes, rinse with water
Dosage and Administration:
Directions hold can at 10 inches distance spray enough product on hands to cover all surfaces. rub hands together until dry supervise children under 6 years of age when using this product to avoid swallowing
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - extra stength hand sanitizer spray alcohol antiseptic 80% packge size ranges between 51g (100 ml) to 252g (500 ml) principal display panel - extra stength hand sanitizer
Further Questions:
Questions ? 1-866-923-2665 manufactured in canada by empack spraytech inc., 98 walker drive, brampton, on, l6t 4h6 upc please recycle (+ logo) lot # and expiry date to be embossed on the tube seal