Huureka Sanitizer
Hypochlorous Acid
Kews Corporation
Human Otc Drug
NDC 75644-001Huureka Sanitizer also known as Hypochlorous Acid is a human otc drug labeled by 'Kews Corporation'. National Drug Code (NDC) number for Huureka Sanitizer is 75644-001. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Huureka Sanitizer drug includes Hypochlorous Acid - .007 mg/mL . The currest status of Huureka Sanitizer drug is Active.
Drug Information:
| Drug NDC: | 75644-001 |
| 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: | Huureka 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: | Hypochlorous Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kews Corporation |
| 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: | HYPOCHLOROUS ACID - .007 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: | UNAPPROVED DRUG OTHER |
| 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 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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. |
| 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: | KEWS CORPORATION
|
| 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: | 712K4CDC10
|
| 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 |
|---|
| 75644-001-01 | 100 mL in 1 BOTTLE, SPRAY (75644-001-01) | 01 May, 2020 | N/A | No |
| 75644-001-02 | 500 mL in 1 BOTTLE, SPRAY (75644-001-02) | 01 May, 2020 | N/A | No |
| 75644-001-03 | 20000 mL in 1 JUG (75644-001-03) | 01 May, 2020 | N/A | No |
| 75644-001-04 | 2000 mL in 1 JUG (75644-001-04) | 05 Aug, 2020 | N/A | No |
| 75644-001-05 | 4000 mL in 1 JUG (75644-001-05) | 05 Aug, 2020 | N/A | No |
| 75644-001-06 | 10000 mL in 1 JUG (75644-001-06) | 05 Aug, 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: for personal sanitizing to decrease bacteria on skin. recommened for repeated use.
Product Elements:
Huureka sanitizer hypochlorous acid hypochlorous acid hypochlorous acid water
Indications and Usage:
Purpose antimicrobial
Warnings:
Warnings: for external use
Dosage and Administration:
Directions for use: use when soap and water not available to supplement regular hand washing. apply liberally to hands and rub hands thoroughly until product is dried. spray enough to the suspected tool, furniture and space.
Package Label Principal Display Panel:
100 ml pdp 100ml ndc 75644-001-001 huureka 100ml pdp
500 ml pdp 500 ml ndc 75644-001-002 huureka 500ml pdp
2 lt pdp 2 lt pdp 75644-001-04 huureka 2lt pdp
4 lt pdp 4 lt pdp, ndc: 75644-001-05 huureka 4lt pdp
10 lt pdp 10 lt pdp, ndc 75644-001-06 huureka 10l pdp
20lt pdp 20 lt ndc 75644-001-003 huureka 20lt pdp