NDC 74631-003 Dgp High Performance Hand Sanitizer Gel

Ethyl Alcohol

NDC Product Code 74631-003

NDC 74631-003-06

Package Description: 946 mL in 1 BOTTLE, PUMP

NDC 74631-003-07

Package Description: 3785 mL in 1 BOTTLE

NDC 74631-003-09

Package Description: 208198 mL in 1 DRUM

NDC Product Information

Dgp High Performance Hand Sanitizer Gel with NDC 74631-003 is a a human over the counter drug product labeled by Dynamic Green Products, Inc.. The generic name of Dgp High Performance Hand Sanitizer Gel is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dynamic Green Products, Inc.

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.

Dgp High Performance Hand Sanitizer Gel 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 72 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)

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.
  • 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: Dynamic Green Products, Inc.
Labeler Code: 74631
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: 07-02-2020 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.

Dgp High Performance Hand Sanitizer Gel Product Label Images

Dgp High Performance Hand Sanitizer Gel 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 72%


Hand & Skin Antiseptic

Indications & Usage

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin


For external use onlyFlammable: Keep away from heat and flame

Otc - When Using

* Avoid contact with eyes. If contact occurs flush eyes thoroughly with clean and cool water* Do not ingest or inhale

Stop Use And Ask A Doctor

* If irritation or redness develops, and/or you have open wounds or serious burns.

Stop Use

* If irritation or redness develops* Have open wounds or serious burns

Keep Out Of Reach Of Children

* If swallowed, get medical help or contact a Poison Control Center immediately


* Apply a small amount of hand sanitizer each use to clean and protect hands* Work thoroughly onto hands and allow to dry without wiping* Reapply as needed

Inactive Ingredients

Water, Glycerin, Tocopheryl Acetate (Vitamin E), Hydroxypropyl Cellulose, Fragrance

* Please review the disclaimer below.