NDC 71080-0022 Hand Sanitizer Mist


NDC Product Code 71080-0022

NDC 71080-0022-1

Package Description: 17 mL in 1 CARTON

NDC 71080-0022-2

Package Description: 17 mL in 1 CARTON

NDC 71080-0022-3

Package Description: 17 mL in 1 CARTON

NDC 71080-0022-4

Package Description: 17 mL in 1 CARTON

NDC 71080-0022-5

Package Description: 17 mL in 1 CARTON

NDC Product Information

Hand Sanitizer Mist with NDC 71080-0022 is a a human over the counter drug product labeled by Gtg Wellness Co., Ltd.. The generic name of Hand Sanitizer Mist is alcohol. The product's dosage form is spray and is administered via topical form.

Labeler Name: Gtg Wellness 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.

Hand Sanitizer 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.

  • ALCOHOL 11.9 g/17mL

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: Gtg Wellness Co., Ltd.
Labeler Code: 71080
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: 05-10-2021 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.

Hand Sanitizer 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

Alcohol 70% w/w

Inactive Ingredients

Water, Glycerin, Fragrance, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Sophora Angustifolia Root Extract




• Flammable. Keep away from heat and flame.• For external use only.--------------------------------------------------------------------------------------------------------Do not use• on children less than 2 months old, or on open skin wounds.--------------------------------------------------------------------------------------------------------When using this product • avoid contact with eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.--------------------------------------------------------------------------------------------------------Stop use and ask a doctor • if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away at (800) 222-1222.


■ to help reduce bacteria on skin.


■ Place enough sanitizer on hands to cover all surfaces.■ Rub hands until dry.■ Children should be supervised when using this product to avoid swallowing .

Other Information

■ Store between 15-30°C (59-86°F)■ Avoid freezing and excessive heat above 40°C (104°F)


• FCO Genesis I, Inc • www.fcogen1.com • 1-888-970-7617

* Please review the disclaimer below.