NDC 74080-040 New Hansan Hand Sanitizer 500ml

Alcohol

NDC Product Code 74080-040

NDC 74080-040-01

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

New Hansan Hand Sanitizer 500ml with NDC 74080-040 is a a human over the counter drug product labeled by Bb & Co., Ltd.. The generic name of New Hansan Hand Sanitizer 500ml is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Bb & Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

New Hansan Hand Sanitizer 500ml 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 350 g/500mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

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: Bb & Co., Ltd.
Labeler Code: 74080
FDA Application Number: part333E 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: 03-01-2020 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 - 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.

New Hansan Hand Sanitizer 500ml Product Label Images

New Hansan Hand Sanitizer 500ml 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

ACTIVE INGREDIENT: ALCOHOL 70.0%

Inactive Ingredient

INACTIVE INGREDIENTS:Water, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Calendula Officinalis Extract, Flavor

Purpose

PURPOSE: SANITIZER

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.

Uses:

Uses : Hand sanitizer to help reduce bacteria on the skin.

Warnings

Warnings:Flammable. Keep away from fire or flame.For external use only.When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions:• Put 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 this product.

Other Information

Other Information:• Store below 90°F(32°C)• May discolor certain fabrics or surfaces

* Please review the disclaimer below.