NDC 82352-001 Sdg High Level Disinfectant

Chlorine-containing Disinfectant

NDC Product Code 82352-001

NDC CODE: 82352-001

Proprietary Name: Sdg High Level Disinfectant 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: Chlorine-containing Disinfectant 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

  • 82352 - Defeng Xingyuan (jiangsu) Biotechnology Co., Ltd.

NDC 82352-001-01

Package Description: 230 mL in 1 BOTTLE

NDC Product Information

Sdg High Level Disinfectant with NDC 82352-001 is a a human over the counter drug product labeled by Defeng Xingyuan (jiangsu) Biotechnology Co., Ltd.. The generic name of Sdg High Level Disinfectant is chlorine-containing disinfectant. The product's dosage form is liquid and is administered via topical form.

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.

Sdg High Level 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.


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: Defeng Xingyuan (jiangsu) Biotechnology Co., Ltd.
Labeler Code: 82352
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: 10-27-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sdg High Level Disinfectant Product Label Images

Sdg High Level 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

Method Of Use

Surgical hand disinfection:It can be washed and sprayed with stock solution. It can be dried naturally after use. It is not necessary to wash with clean waterDisinfection of medical devices:It can be soaked in stock solution or sprayed directlySkin disinfection:The medical gauze soaked in the original solution or soaked with the original solution can be washed repeatedly, wet applied to the disinfected part or sprayed directly on the disinfected part.Oral and pharyngeal disinfection:Gargle or spray repeatedly with stock solution for 3-5 timesMucosal disinfection:It can be sprayed with stock solution or directly washed after the stock solution is poured into the washerDisinfection of object surface:It can be scrubbed or sprayed directly with medical gauze soaked in stock solution or soaked with stock solutionDisinfection of fruits, vegetables and tableware:It can be soaked in the stock solution or sprayed directly. It can be dried naturally after use without washing with clean waterTableware cleaning enterprises, food processing equipment and tool disinfection:It can be soaked in the stock solution or sprayed directly. It can be dried naturally after use without washing with clean water

Inactive Ingredient

WATER

Scope Of Application

It is applicable to the sanitary cleaning and disinfection of skin, mouth, pharynx, object surface, fruits and vegetables and tableware in people's daily life; It is applicable to the disinfection of hands, medical instruments and vaginal mucosa (only for diagnosis and treatment in medical and health institutions) of medical personnel during surgery; It is suitable for tableware disinfection of production equipment of tableware cleaning enterprises and tableware distribution in catering industry; It is applicable to the disinfection of equipment and tools in direct contact with food in food processing enterprises.

Otc - Active Ingredient

Sodium chloride

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Category Of Killing Microorganisms

SDG ™ The disinfectant has bactericidal effect on Staphylococcus aureus, Escherichia coli, Candida albicans and Bacillus subtilis black variant spores; It can inactivate poliovirus. The bactericidal rate reached 99.9999%, which is characterized by safety, reliability, no side effects, no irritation, completely killing COVID-19 and environmental protection.

Storage And Handling

Sealed storage in a cool, dry and dark place

Warnings

1. This product should be sealed and stored away from light;

2. Avoid prolonged exposure of liquids to air;

3. The product shall be stored in the environment within 4 ℃ - 40 ℃;

4. Valid for one year (use within 90 days after unsealing).

* Please review the disclaimer below.