NDC 79543-201 Clean-us Purichlo Sanitizer-spray

Hypochlorous Acid

NDC Product Code 79543-201

NDC 79543-201-01

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC Product Information

Clean-us Purichlo Sanitizer-spray with NDC 79543-201 is a a human over the counter drug product labeled by Geumwon International Co., Ltd. The generic name of Clean-us Purichlo Sanitizer-spray is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Geumwon International 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.

Clean-us Purichlo Sanitizer-spray 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 .005 g/100mL

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: Geumwon International Co., Ltd
Labeler Code: 79543
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: 07-10-2020 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.

Clean-us Purichlo Sanitizer-spray Product Label Images

Clean-us Purichlo Sanitizer-spray 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 Ingredients

Hypochlorous Acid 0.005%

Purpose

Sanitizer

Uses

Purpose of sterilizing the surface of instruments and objects.

Warning

This Products are for use on surface, Not humans.Follow the contact time as directed in the directions.Do not touch the surface during the contact time.Do not dilute, use the solution as is.

Stop Use And Ask A Doctor If Irritation Or Redness Occurs.

Do not inhale or ingest.

Keep Out Of Reach Of Children.

Make sure to supervise the use of products by children, the elderly, the disabled, and others who vulnerable to the use of products.

Directions

Spray on the surface of sterilizing object in a wide range.Spray on a target that requires sterilization and let it dry naturally or wipe with a dry towel after 30 seconds.If you can’t spray directly on the surface, you can spray to the clean cloth and wipe it off.

Other Information

If this product is exposed to external air for a long time it may react with UV or air and be restored to water.Keep it sealed and store in a cool and dark place.

Inactive Ingredients

Water 99.995%

* Please review the disclaimer below.