NDC 21749-821 Purell Professional Advanced Hand Sanitizer Fragrance Free Foam
Alcohol
NDC Product Code 21749-821
Proprietary Name: Purell Professional Advanced Hand Sanitizer Fragrance Free 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: 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
- 21749 - Gojo Industries, Inc.
- 21749-821 - Purell Professional Advanced Hand Sanitizer Fragrance Free Foam
NDC 21749-821-53
Package Description: 535 mL in 1 PACKAGE
NDC 21749-821-89
Package Description: 1200 mL in 1 PACKAGE
NDC Product Information
Purell Professional Advanced Hand Sanitizer Fragrance Free Foam with NDC 21749-821 is a a human over the counter drug product labeled by Gojo Industries, Inc.. The generic name of Purell Professional Advanced Hand Sanitizer Fragrance Free Foam is alcohol. The product's dosage form is liquid and is administered via topical form.
Labeler Name: Gojo Industries, 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.
Purell Professional Advanced Hand Sanitizer Fragrance Free 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.
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)
- CAPRYLYL GLYCOL (UNII: 00YIU5438U)
- GLYCERIN (UNII: PDC6A3C0OX)
- ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
- .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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: Gojo Industries, Inc.
Labeler Code: 21749
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: 09-05-2017 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.
Purell Professional Advanced Hand Sanitizer Fragrance Free Foam Product Label Images
Purell Professional Advanced Hand Sanitizer Fragrance Free 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
- Purpose
- Uses
- Warnings
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Inactive Ingredients
Active Ingredient
Ethyl alcohol 70% v/v
Purpose
Antimicrobial
Uses
- Hand sanitizer to help reduce bacteria on the skin that cause diseaseRecommended for repeated use
Warnings
Flammable. Keep away from fire or flame.For external use only
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash 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 right away.
Directions
- Place enough product in your palm to thoroughly cover your handsRun hands together briskly until dryChildren under 6 years of age should be supervised when using this product.
Inactive Ingredients
Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate
* Please review the disclaimer below.