NDC 80998-0001 Sani-health Sanitizer

Chlorine Dioxide

NDC Product Code 80998-0001

NDC 80998-0001-1

Package Description: 20000 mL in 1 CONTAINER

NDC Product Information

Sani-health Sanitizer with NDC 80998-0001 is a a human over the counter drug product labeled by Chorogholdings Co., Ltd.. The generic name of Sani-health Sanitizer is chlorine dioxide. The product's dosage form is spray and is administered via topical form.

Labeler Name: Chorogholdings Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Sani-health 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.

  • CHLORINE DIOXIDE .003 g/20000mL

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: Chorogholdings Co., Ltd.
Labeler Code: 80998
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: 11-03-2020 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.

Sani-health Sanitizer Product Label Images

Sani-health 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

Otc - Active Ingredient

Chlorine dioxide

Inactive Ingredient

Water

Otc - Purpose

Antiseptic

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

■ Spray enough spray into the room to be protected.■Enough for spaces where contamination is expected.■ Children under 6years of age should be supervisedwhen using this products.

Warnings

■For external use only.■Store in the shade after use and close the cap tightly.■When using this product do not use in or near the eyes,In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor if irritation or rash appears and lasts.

Dosage & Administration

For external use only

* Please review the disclaimer below.