NDC 75644-004 Tok And Care Sanitizer

Hypochlorous Acid

NDC Product Code 75644-004

NDC 75644-004-01

Package Description: 8 mL in 1 POUCH

NDC 75644-004-02

Package Description: 10 POUCH in 1 BOX > 8 mL in 1 POUCH (75644-004-01)

NDC 75644-004-03

Package Description: 50 mL in 1 BOTTLE, SPRAY

NDC 75644-004-04

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC Product Information

Tok And Care Sanitizer with NDC 75644-004 is a a human over the counter drug product labeled by Kews Corporation. The generic name of Tok And Care Sanitizer is hypochlorous acid. 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.

Tok And Care 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.


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: 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: 06-18-2021 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.

Tok And Care 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

Active Ingredient

Hypochlorous Acid ------ 0.0.007%

Purpose

Antimicrobial

Directions:

Use when soap and water not available to supplement regular hand washing.Press the front fingerprint shape to wash hands, skin.Or rub hands with a tissueRub suspected tool, furniture, and space.

Inactive Ingredient(S)

Water

Intended Use

For Personal sanitizing to decrease virus and baceteria on skin

Warnings:

For external use only

Purpose:

For personal sanitizing to decrease virus and bacteria on skin

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.

0.27 Fl Oz (8 Ml) Pdp

0.27 fl oz (8mL) NDC 75644-004-01

0.27Fl Oz (8Ml Ea) X 10 Pouches Pdp

0.27 fl oz (8ml) X 10 Pouches NDC 75644-004-02

1.69 Fl Oz (50Ml) Pdp

1.69 fl oz (50ml) PDP 75644-004-03

3.38 Fl Oz (100Ml) Pdp

3.38 Fl oz (100ml) PDP, NDC: 75644-004-04

* Please review the disclaimer below.