NDC 76591-104 Fresh Hand Foaming Hand Sanitizer Alcohol Foam

Ethyl Alcohol

NDC Product Code 76591-104

NDC CODE: 76591-104

Proprietary Name: Fresh Hand Foaming Hand Sanitizer Alcohol Foam What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ethyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 76591 - Guangzhou Gotdya Fine Chemical Co., Ltd.
    • 76591-104 - Fresh Hand Foaming Hand Sanitizer Alcohol Foam

NDC 76591-104-11

Package Description: 1000 mL in 1 BOTTLE

NDC Product Information

Fresh Hand Foaming Hand Sanitizer Alcohol Foam with NDC 76591-104 is a a human over the counter drug product labeled by Guangzhou Gotdya Fine Chemical Co., Ltd.. The generic name of Fresh Hand Foaming Hand Sanitizer Alcohol Foam is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Guangzhou Gotdya Fine Chemical Co., Ltd.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Fresh Hand Foaming Hand Sanitizer Alcohol Foam 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 mL/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.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)

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: Guangzhou Gotdya Fine Chemical Co., Ltd.
Labeler Code: 76591
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: 08-04-2020 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: 12-31-2022 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.

Fresh Hand Foaming Hand Sanitizer Alcohol Foam Product Label Images

Fresh Hand Foaming Hand Sanitizer Alcohol Foam 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

Ethyl Alcohol 70 %

Purpose

Antibacterial

ANTIBACTERIAL

Uses

  • Hand sanitizer to help reduce bacteria on the skin.

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.Stop use and ask a doctor if irritation or rash appears and lasts.

When Using This Product

  • Avoid contact with eyes. In case of eye contact, flush with water

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

  • Place enough product on your palm to thoroughly cover your handsRub hands together briskly until dry

Inactive Ingredients

Water, Isopropyl Alcohol, Propylene Glycol, PEG-12 Dimethicone Crosspolymer, BIS-PEG-12 Dimethicone.

* Please review the disclaimer below.