NDC 79963-100 Foh Health Essentials Sanitizer Gel

Hand Sanitizer

NDC Product Code 79963-100

NDC 79963-100-02

Package Description: 59 mL in 1 BOTTLE

NDC 79963-100-28

Package Description: 3785 mL in 1 BOTTLE

NDC Product Information

Foh Health Essentials Sanitizer Gel with NDC 79963-100 is a a human over the counter drug product labeled by Foh Inc. The generic name of Foh Health Essentials Sanitizer Gel is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Foh Inc

Dosage Form: Gel - 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.

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.

Foh Health Essentials Sanitizer Gel 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.

  • ALCOHOL 70 mL/100mL

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.
  • 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: Foh Inc
Labeler Code: 79963
FDA Application Number: part333A 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: 08-25-2020 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.

Foh Health Essentials Sanitizer Gel 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


For external use only: hands. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation andredness develop or condition persists for more than 72 hours

Active Ingredient

Ethyl alcohol 70%



Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center rightaway


To decrease bacteria on the skin that could cause disease ▪ Recommended for repeated use

Inactive Ingredients

Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer,Triethanolamine, Vitamin E (Tocopheryl Acetate).


Wet hands thoroughly with product and allow to dry without wiping ▪ For children under 6,use only under adult supervision ▪ Not recommended for infants.

Other Information

Do not store above 105°F ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics.70% ALCOHOLKills 99.99% of GermsAloe Vera & Vitamin EFragrance Free*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.Distributed by: FOH Inc Miami, FL 33138fohhealth.comCRUELTY FREEVEGANPARABEN FREENO SULFATESMADE IN USA

* Please review the disclaimer below.