NDC 77263-001 Hclo Disinfectant

Hypochlorous Acid

NDC Product Code 77263-001

NDC 77263-001-01

Package Description: 60 mL in 1 BOTTLE

NDC 77263-001-02

Package Description: 100 mL in 1 BOTTLE

NDC 77263-001-03

Package Description: 500 mL in 1 BOTTLE

NDC 77263-001-04

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Hclo Disinfectant with NDC 77263-001 is a a human over the counter drug product labeled by Suzhou Hvha Medical Technology Development Co.,ltd.. The generic name of Hclo Disinfectant is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Suzhou Hvha Medical Technology Development 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.

Hclo Disinfectant 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 .1 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)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM SILICATE (UNII: IJF18F77L3)

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: Suzhou Hvha Medical Technology Development Co.,ltd.
Labeler Code: 77263
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: 05-03-2020 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.

Hclo Disinfectant 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

Main Ingredient

Effective Chlorine 90-110mg/L

Properties

This product is colorless transparent liquid

Categories Of Microorganism To Be Killed

This product kills the enteric pathogenic bacteria, pyococcus, pathogenic saccharomycetes and common bacteria in nosocomial infection.

Application Scope

Suitable for disinfecting hygienic hand, Air, Object surface, Fabric, Fruit and vegetable

Indication For Use

1. Disinfection of hand: Spray the original solution once, take effect for 5 minutes.2. Disinfection of air: Spray the original solution once, take effect for 20 minutes.3. Disinfection of fabric: Spray the original solution once, take effect for 5 minutes.4. Disinfection of surface of object: Spray the original solution once, take effect for 5 minutes.5. Disinfection of fruit or vegetable: Spray the original solution, take effect for 5 minutes.

Notices

Use by children must be under tutelage of adult.Keep out of reach of children and abnormal people.

Warnings

Avoid high temperature or open fireThis product is acid substance and avoid using together with alkaline substance.After the product is opened, the service life is two weeks.This product is prohibited using together with products containing hydrochloric acid.

Function Mechanism

HCLO is a kind of strong oxidant and it is decomposed into nascent oxygen which is strong oxidability to makes proteins and other substances of bacteria or virus denatured and play a bactericidal effect. HCLO infiltrates into the bacteria or virus and oxidizes with organic macromolecules such as protein, nucleic acid and enzyme, and enzymes to kill the pathogenic microorganisms. The chloride ion generated from HCLO can also significantly change the osmotic pressure of bacteria or virus, making their cells lose viability and die.

Storage

Seal and store away from light at cool temperatureShelf life: 24 months

Inactive Ingredients

Water, Sodium chloride, Sodium silicate

Purpose

Disinfect hand, air, surface of object, fabric, fruit and vegetable

* Please review the disclaimer below.