NDC 40760-020 Hypochlorous Acid Disinfecting

Hypochlorous Acid Disinfecting

NDC Product Code 40760-020

NDC CODE: 40760-020

Proprietary Name: Hypochlorous Acid Disinfecting What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hypochlorous Acid Disinfecting What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 40760 - Huzhou Guoneng New Material Co., Ltd.

NDC 40760-020-01

Package Description: 946 mL in 1 BOTTLE

NDC Product Information

Hypochlorous Acid Disinfecting with NDC 40760-020 is a a human over the counter drug product labeled by Huzhou Guoneng New Material Co., Ltd.. The generic name of Hypochlorous Acid Disinfecting is hypochlorous acid disinfecting. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Huzhou Guoneng New Material Co., Ltd.

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.

Hypochlorous Acid Disinfecting 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 236.5 mg/946mL

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.

Product Labeler Information

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

Labeler Name: Huzhou Guoneng New Material Co., Ltd.
Labeler Code: 40760
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: 12-28-2020 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’.

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Hypochlorous Acid Disinfecting Product Label Images

Hypochlorous Acid Disinfecting 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

Usage Scenario

1. Cleaning and disinfection of hands, skin , mucous membrane,oral cavity and wounds of infants and adults;

2. Disinfection of general objects such as secondary water supply equipment fabrics sheets, athrooms, cars,elevators, furniture, door handes,personal belongings,etc.;

3.Indoor air disinfection

Otc - Purpose

Spray at any time, disinfect at any time Mild and non irritating

Safe and harmless Kills 99.99% of mostillness causing germs

Inactive Ingredient

Purified Water

Otc - Active Ingredient

Slightly acidic hypochlorous acid (effective chlorine concentration 250±15ppm)

Directions

1.For the hands,skin, mucous membranes and wounds cleaning and disinfection ,spray evenly to form vible water droplets,2-4 times per day2.For article surface disinfection, spray or wipe with the product directly.

3.For indoor air disinfection, spray the product directly f use a humidfier for help, air disnfection can be achieved under the atomization effectof the humidfier For general household applicaiton, use 1-2 times of pure water to dilute, dio not dilute in densely populated places.

Storage Conditions

The temperature shall not exceed 30°C and the humidity shall not exceed 80% and sealed for storage without sunlight. It is required to be cool, ventilated and keep away from heat,fire, acid, alkali, reducing substances, and flammable materials.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Do Not Use

This product is different from general disinfection products.Please do not mikxit with other disinfection products except purified water

Otc - Stop Use

The disinfectant ingredient of this product is slichtly acid hypochlorous acid, which is easy to decompose under sunlight due to its chemicalcharactritics. t normal shelf lfe is 12 months Please use it within 3 months ater opening. The daily storage should be in Keep in a closed andopaque container away from sunlight.

Warnings

Avoid contact with eyes.

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