NDC 81797-701 Ko-c100

Chlorine Dioxide

NDC Product Code 81797-701

NDC CODE: 81797-701

Proprietary Name: Ko-c100 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 Dioxide 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
10 MM
Score: 1
Flavor(s):
EGG NOG (C73387)

NDC Code Structure

  • 81797 - Dong Fuh Biotech Co., Ltd.

NDC 81797-701-13

Package Description: 1000 NOT APPLICABLE in 1 PACKAGE > 1 g in 1 NOT APPLICABLE (81797-701-01)

NDC Product Information

Ko-c100 with NDC 81797-701 is a a human over the counter drug product labeled by Dong Fuh Biotech Co., Ltd.. The generic name of Ko-c100 is chlorine dioxide. The product's dosage form is tablet, for solution and is administered via extracorporeal form.

Labeler Name: Dong Fuh Biotech Co., Ltd.

Dosage Form: Tablet, For Solution - A tablet that forms a solution when placed in a liquid.

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.

Ko-c100 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.

  • CHLORINE DIOXIDE .1 g/g

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.

  • MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

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

  • Extracorporeal - Administration outside of the body.

Product Labeler Information

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

Labeler Name: Dong Fuh Biotech Co., Ltd.
Labeler Code: 81797
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: 04-09-2021 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.

Ko-c100 Product Label Images

Ko-c100 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(S)

Chlorine Dioxide 0.1g/1g. Purpose: Sterilization, disinfection

Purpose

Sterilization, disinfection

Use(S)

It is suitable for environmental disinfection in public spaces, public transportation, schools, hospitals, stores, restaurants, homes, food factories, and animal husbandry.

Warnings

External Use Only. Do not take orally.

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Directions

Take out 1 KO-100C Disinfectant, add it to a container filled with 1000c.c. water, let it stand for 1-3 minutes to dissolve into a light yellow disinfectant stock solution, and then distribute it to various containers for immediate use.

Other Information

  • Store at a cool placeValid period: 2 years

Inactive Ingredients

Citric Acid, Magnesium Sulfate, Sodium Bicarbonate, Sodium Chloride

* Please review the disclaimer below.