NDC 80659-301 Purifi Hand Sanitizer

Benzalkonium Chloride

NDC Product Code 80659-301

NDC 80659-301-01

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 80659-301-02

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 80659-301-03

Package Description: 3800 mL in 1 BOTTLE, PLASTIC

NDC 80659-301-04

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC 80659-301-05

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Purifi Hand Sanitizer with NDC 80659-301 is a a human over the counter drug product labeled by Purifi Llc. The generic name of Purifi Hand Sanitizer is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Purifi Llc

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.

Purifi Hand 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: Purifi Llc
Labeler Code: 80659
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: 12-10-2020 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.

Purifi Hand Sanitizer Product Label Images

Purifi Hand 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


Drug Facts

Otc - Active Ingredient

Active ingredientBenzalkonium Chloride 0.13%

Otc - Purpose


Indications & Usage

UsesHand sanitizing to help reduce bacteria on the skin


WarningsFor external use only.

Otc - When Using

When using this product avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

Otc - Stop Use

​Stop use and ask a doctor if irritation or redness appears and lasts

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

DirectionsApply liberally to hands and gently rub until dry. Reapply every 6 hours.

Storage And Handling

Other informationStore above 32°F (0°C) and below 100°F (38.8°C)

Inactive Ingredient

Inactive ingredientspurified water, glycerin, aloe barbadensis leaf juice

* Please review the disclaimer below.