NDC 75795-499 Patriot Hand Sanitizer Gallon

Hand Sanitizer

NDC Product Code 75795-499

NDC 75795-499-01

Package Description: 3785.4 mL in 1 BOTTLE

NDC 75795-499-02

Package Description: 59.15 mL in 1 BOTTLE

NDC 75795-499-04

Package Description: 118.3 mL in 1 BOTTLE

NDC 75795-499-08

Package Description: 236.59 mL in 1 BOTTLE

NDC 75795-499-16

Package Description: 473.18 mL in 1 BOTTLE

NDC Product Information

Patriot Hand Sanitizer Gallon with NDC 75795-499 is a a human over the counter drug product labeled by Dfmprintpak3709. The generic name of Patriot Hand Sanitizer Gallon is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dfmprintpak3709

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.

Patriot Hand Sanitizer Gallon 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 2914.76 mL/3785.4mL

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: Dfmprintpak3709
Labeler Code: 75795
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: 05-31-2020 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.

Patriot Hand Sanitizer Gallon Product Label Images

Patriot Hand Sanitizer Gallon 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

Inactive Ingredients

Inactive Ingredeints for this product are:Glycerin Hydrogen Peroxide

Otc - Keep Out Of Reach Of Children

Keep Product out of reach of children.

Indications And Use

Indications and Use for this product:Wet hands thoroughly with product and allow to dry without wiping.

Otc Purpose

Purpose of this product is to use for hand washing to decrease bacteriaon the skin only when water is unavailable.

Dosage And Administration Section

Dosage is a small amount of gel into palm of hands,to be rubbed into hands.

Active Ingredient For Otc Product

Active Ingredient in this product is Ethyl Alcohol 80%

Warnings Section

Warnings Section:Do not ingest product, for external use only.Flammable, keep away from fire and flames,See attached product labelPatriot Sanitizer Label FINAL ART.jpg

Hand Sanitizer Active Ingredient

Ethyl Alcohol 80%

* Please review the disclaimer below.