NDC 75644-001 Huureka Sanitizer

Hypochlorous Acid

NDC Product Code 75644-001

NDC 75644-001-01

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 75644-001-02

Package Description: 500 mL in 1 BOTTLE, SPRAY

NDC 75644-001-03

Package Description: 20000 mL in 1 JUG

NDC 75644-001-04

Package Description: 2000 mL in 1 JUG

NDC 75644-001-05

Package Description: 4000 mL in 1 JUG

NDC 75644-001-06

Package Description: 10000 mL in 1 JUG

NDC Product Information

Huureka Sanitizer with NDC 75644-001 is a a human over the counter drug product labeled by Kews Corporation. The generic name of Huureka Sanitizer is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kews Corporation

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Huureka Sanitizer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYPOCHLOROUS ACID .007 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kews Corporation
Labeler Code: 75644
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Huureka Sanitizer Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Hypochlorous Acid ------ 0.0.007%

Purpose

Antimicrobial

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.

Inactive Ingredient(S)

Water

Intended Use

For Personal sanitizing to decrease baceteria on skinRecommended for repeated use.

Warnings:

For External Use

Purpose:

For personal sanitizing to decrease bacteria on skin.Recommened for repeated use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

500 Ml Pdp

500 mL NDC 75644-001-002

20Lt Pdp

20 LT NDC 75644-001-003

100 Ml Pdp

100mL NDC 75644-001-001

* Please review the disclaimer below.