NDC 74085-0001 Sense Fresh Quick Hand Sanitizing

Alcohol

NDC Product Code 74085-0001

NDC 74085-0001-1

Package Description: 473 mL in 1 BOTTLE

NDC 74085-0001-2

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Sense Fresh Quick Hand Sanitizing with NDC 74085-0001 is a a human over the counter drug product labeled by Biochem Korea Co Ltd. The generic name of Sense Fresh Quick Hand Sanitizing is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Biochem Korea 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.

Sense Fresh Quick Hand Sanitizing 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.

  • ALCOHOL 70 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.

  • BIS-OLEAMIDO ISOPROPYL ALCOHOL (UNII: P3T9YD2B5N)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

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: Biochem Korea Co Ltd
Labeler Code: 74085
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-01-2020 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.

Sense Fresh Quick Hand Sanitizing Product Label Images

Sense Fresh Quick Hand Sanitizing 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

Ethyl alcohol

Otc - Purpose

The convenient Sense Fresh Advanced Instant Hand Sanitizer with Aloe is an antimicrobial liquid that contains 70 percent ethyl alcohol to help reduce the number of germs on hands, and three moisturizers to help keep skin hydrated. No rinsing with water or drying with towels is needed. Alcohol-based hand sanitizers can quickly reduce the number of germs on hands within 30 seconds. The hand sanitizer meets U.S. Food and Drug Administration (FDA) healthcare personnel hand-washing requirements. It’s perfect for on-the-go uses when traveling outside of the home, and fits neatly in purses, backpacks or briefcases.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

Just spray enough product in your palm to cover hands and rub hands together briskly until dry.Children under 6 years of age should be supervised when using Sense Fresh.Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

■ Flammable. Keep away from fire or flame.■ For external use only.■ Do not use in eyes.■ lf swallowed, get medical help promptly.■ Stop use, ask doctor lf irritation occurs.■ Keep out of reach of children.

Dosage & Administration

For external use only

Inactive Ingredient

Water, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, propolis extract, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates C10 30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

* Please review the disclaimer below.