NDC 75644-002 Absoclean-s Sanitizing Mist

Hypochlorous Acid

NDC Product Code 75644-002

NDC 75644-002-01

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 75644-002-02

Package Description: 500 mL in 1 BOTTLE, SPRAY

NDC 75644-002-03

Package Description: 20000 mL in 1 JUG

NDC Product Information

Absoclean-s Sanitizing Mist with NDC 75644-002 is a a human over the counter drug product labeled by Kews Corporation. The generic name of Absoclean-s Sanitizing Mist is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kews Corporation

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.

Absoclean-s Sanitizing Mist 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 .006 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)

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: Kews Corporation
Labeler Code: 75644
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: 04-30-2020 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.

Absoclean-s Sanitizing Mist Product Label Images

Absoclean-s Sanitizing Mist 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

HYPOCHLOROUS ACID -- 0.006%

Inactive Ingredients

Water

Purpose

Antimicrobial

-For personal sanitzing to decrease bacteria on skin-Recommended for repeated use

Directions For Use

-Use when soap and water not available to supplement regular hand washing.-Apply liberally to hands and rub hands thorougly until product is dried-Spray enough to the suspected tool, furniture and space.

Intended Use

-For personal sanitizing to decrease bacteria on skin-Recommended for repeated use

Warnings

For External Use

Otc - Keep Out Of Reach Of Children

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

100Ml Pdp

100mL NDC 75644-002-01

500Ml Pdp

500mL NDC 75644-002-02

20Lt Pdp

20LT NDC 75644-002-03

* Please review the disclaimer below.