NDC 77071-001 Glanhealth Hand Sanitizer Advanced
Benzalkonium Chloride Aerosol, Foam Topical

Product Information

What is NDC 77071-001?

The NDC code 77071-001 is assigned by the FDA to the product Glanhealth Hand Sanitizer Advanced which is a human over the counter drug product labeled by Dalrada Health Products. The generic name of Glanhealth Hand Sanitizer Advanced is benzalkonium chloride. The product's dosage form is aerosol, foam and is administered via topical form. The product is distributed in 6 packages with assigned NDC codes 77071-001-00 3780 ml in 1 bottle , 77071-001-01 59 ml in 1 bottle , 77071-001-02 150 ml in 1 bottle , 77071-001-03 50 ml in 1 bottle , 77071-001-04 500 ml in 1 bottle , 77071-001-05 18930 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code77071-001
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.
Glanhealth Hand Sanitizer Advanced
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.
Benzalkonium Chloride
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 FormAerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
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.
Dalrada Health Products
Labeler Code77071
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.
01-01-2020
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.
12-31-2023
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

What are the uses for Glanhealth Hand Sanitizer Advanced?


Product Packages

NDC Code 77071-001-00

Package Description: 3780 mL in 1 BOTTLE

NDC Code 77071-001-01

Package Description: 59 mL in 1 BOTTLE

NDC Code 77071-001-02

Package Description: 150 mL in 1 BOTTLE

NDC Code 77071-001-03

Package Description: 50 mL in 1 BOTTLE

NDC Code 77071-001-04

Package Description: 500 mL in 1 BOTTLE

NDC Code 77071-001-05

Package Description: 18930 mL in 1 BOTTLE

Product Details

What are Glanhealth Hand Sanitizer Advanced Active Ingredients?

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.

Glanhealth Hand Sanitizer Advanced Active Ingredients UNII Codes

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Glanhealth Hand Sanitizer Advanced Inactive Ingredients UNII Codes

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.

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Glanhealth Hand Sanitizer Advanced Product Label

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.

Product Label Table of Contents



Active Ingredient:



Benzalkonium Chloride 0.13%


Purpose



Hand & Skin Sanitizer


Uses:



GlanHealth's Advanced Hand Sanitizer provides revolutionary protection in an alcohol-free formula. The Scientifically-proven solutiion kills harmful germs, bacteria, and microbes, and gently soothes and softens skin with aloe vera. Recommended for repeated use.


Warnings:



  • Do not freeze
  • For external use only

Do Not Use



  • in ears, eyes or mouth

When Using This Product,



  • avoid contact with the eyes
  • In case of contact, flush eyes with water

Stop Use And Ask Doctor If



  • redness or irritation develops and persists for more than 72 hours

Keep Out Of Reach Of Children



Children should be supervised when using this product.


Directions:



  • Apply liberally to the palms of the hands or areas of damaged skin. Rub into skin until dry. Recommended for repeated use.

Other Information:



Store in a cool dry place below 104° F(40°C).


Inactive Ingredients



Aloe Barbadensis Leaf Juice, Aqua, Citric Acid, Caprylyl Glucoside, Laureth-4, Polyhexanide, Phenoxyethanol, Triethoxysilylpropyl Steardimonium Chloride.


Questions?



1(855) 8692-1526, Mon-Fri 9:00AM-5:00PM (PST)


Package Labeling:3.78L




Package Labeling:59Ml




* Please review the disclaimer below.