NDC 77071-001 Glanhealth Hand Sanitizer Advanced

Benzalkonium Chloride

NDC Product Code 77071-001

NDC 77071-001-00

Package Description: 3780 mL in 1 BOTTLE

NDC 77071-001-01

Package Description: 59 mL in 1 BOTTLE

NDC 77071-001-02

Package Description: 150 mL in 1 BOTTLE

NDC Product Information

Glanhealth Hand Sanitizer Advanced with NDC 77071-001 is a 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.

Labeler Name: Dalrada Health Products

Dosage Form: Aerosol, 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.

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.

Glanhealth Hand Sanitizer Advanced 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.

  • BENZALKONIUM CHLORIDE 1.3 mg/mL

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • LAURETH-4 (UNII: 6HQ855798J)
  • POLIHEXANIDE (UNII: 322U039GMF)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

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.
  • 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: Dalrada Health Products
Labeler Code: 77071
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: 01-01-2020 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.

Glanhealth Hand Sanitizer Advanced Product Label Images

Glanhealth Hand Sanitizer Advanced 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%

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 freezeFor external use only

Do Not Use

  • In ears, eyes or mouth

When Using This Product,

  • Avoid contact with the eyesIn 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)

* Please review the disclaimer below.