NDC 79380-012 Fusoni Hand Sanitizer With Moisturizer Plus Blue

Alcohol

NDC Product Code 79380-012

NDC 79380-012-11

Package Description: .946 L in 1 BOTTLE

NDC 79380-012-12

Package Description: 3.785 L in 1 BOTTLE

NDC 79380-012-13

Package Description: 18.93 L in 1 PAIL

NDC 79380-012-14

Package Description: 208.18 L in 1 DRUM

NDC 79380-012-15

Package Description: 1003.03 L in 1 CONTAINER

NDC Product Information

Fusoni Hand Sanitizer With Moisturizer Plus Blue with NDC 79380-012 is a a human over the counter drug product labeled by Fusoni S.a. De C.v.. The generic name of Fusoni Hand Sanitizer With Moisturizer Plus Blue is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Fusoni S.a. De C.v.

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.

Fusoni Hand Sanitizer With Moisturizer Plus Blue 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 .7 L/L

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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
  • PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • AMMONIA (UNII: 5138Q19F1X)

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: Fusoni S.a. De C.v.
Labeler Code: 79380
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: 07-07-2020 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.

Fusoni Hand Sanitizer With Moisturizer Plus Blue 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

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

Flammable, keep away from source of heat, fire or flame.

For external use only. Do not inhale or ingest.

When Using This Product

Do not use in or near the eyes; if contact occurs, rinse eyes

thoroughly with water.
avoid contact with broken skin.

Stop Use And Ask A Doctor If

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep Out Of Reach Of Children

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

Directions

Place enough product in your palm to thoroughly cover your hands and rub them together until dry.

children under 6 years of age should be supervised when using this product.

Other Information

Do not store above 109°F (43°C).

may discolor certain surfaces or fabrics.

Inactive Ingredients

Product 011 "DRUG FACTS Fusoni Hand Sanitizer Plus.jpg":Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Ammonium Hydroxide.Product 012 "DRUG FACTS Fusoni Hand Sanitizer Plus Blue.jpg":Water, Hydroxyethylcellulose, PPG-3 Benzyl Ether Myristate, Citric Acid, Phenoxyethanol, Glycerine, Blue 1, Ammonium Hydroxide.

* Please review the disclaimer below.