NDC 72513-200 8hd Hand And Skin Sanitizer

Benzalkonium Chloride

NDC Product Code 72513-200

NDC 72513-200-01

Package Description: 29.57 mL in 1 BOTTLE

NDC 72513-200-02

Package Description: 59.14 mL in 1 BOTTLE

NDC 72513-200-03

Package Description: 1000 mL in 1 BOTTLE

NDC 72513-200-04

Package Description: 3785.41 mL in 1 JUG

NDC 72513-200-05

Package Description: 208198 mL in 1 DRUM

NDC 72513-200-06

Package Description: 1040988.2 mL in 1 CONTAINER

NDC 72513-200-07

Package Description: 1249185.9 mL in 1 CONTAINER

NDC Product Information

8hd Hand And Skin Sanitizer with NDC 72513-200 is a a human over the counter drug product labeled by Strategia Project Management, Inc.. The generic name of 8hd Hand And Skin Sanitizer is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Strategia Project Management, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

8hd Hand And Skin Sanitizer 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.


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: Strategia Project Management, Inc.
Labeler Code: 72513
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: 12-16-2020 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.

8hd Hand And Skin Sanitizer 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

Benzalkonium Chloride 0.13%




Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.


For external use only.

Do Not Use

In eyes. If contact occurs, flush thoroughly with water.

Stop Use And Ask A Doctor:

If irritation or redness develops, or if condition persists for more than 72 hours.

Keep Out Of Reach Of Children:

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


On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly until entirely dry.

Inactive Ingredients:

Water, Hydrated Silica Complex

* Please review the disclaimer below.