NDC 80899-001 Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol
Alcohol Gel Topical

Product Information

Product Code80899-001
Proprietary Name 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.
Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol
Non-Proprietary Name 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.
Alcohol
Product Type 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.
Human Otc Drug
Dosage FormGel - 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.
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.
Allegrini Spa
Labeler Code80899
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-01-2021
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 80899-001-01

Package Description: 50 mL in 1 BOTTLE

NDC 80899-001-02

Package Description: 500 mL in 1 BOTTLE

NDC 80899-001-03

Package Description: 1000 mL in 1 BOTTLE

NDC 80899-001-04

Package Description: 5000 mL in 1 BOTTLE

Product Details

Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol is a human over the counter drug product labeled by Allegrini Spa. The generic name of Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol is alcohol. The product's dosage form is gel and is administered via topical form.


What are Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CITRAL (UNII: T7EU0O9VPP)
  • GERANIOL (UNII: L837108USY)


* Please review the disclaimer below.

Primagel Plus Rinse-free Antiseptic Hand Sanitizer 70 Ethyl Alcohol Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Ethyl alcohol 70%


Purpose



Antiseptic


Use



For hand washing to decrease bacteria on the skin 


Warnings



For external use only.

Flammable, keep away from fire or flame.


Do Not Use



in the eyes.


Stop Use And Ask A Doctor If



  • Irritation and redness develop.
  • Condition persists for more than 72 hours.

Keep Out Of Reach Of Children.



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


Directions



Wet hands thoroughly with product and allow to dry without wiping.


Other Information



Store in a cool place, away from sources of heat.


Inactive Ingredients



Water, glycerin, propylene glycol, aloe vera leaf juice, methyl gluceth-20, carbomer, aminomethyl propanol, citric acid, fragrance, sodium benzoate, potassium sorbate, limonene, citral, geraniol


Package Labeling:80899-001-03




* Please review the disclaimer below.