NDC 80994-002 Sanitizing Hand

Benzethonium Chloride

NDC Product Code 80994-002

NDC 80994-002-01

Package Description: 250 mL in 1 BOTTLE

NDC 80994-002-02

Package Description: 400 mL in 1 BOTTLE

NDC 80994-002-03

Package Description: 3785 mL in 1 BOTTLE

NDC 80994-002-04

Package Description: 150 PACKET in 1 BOX > 1.2 mL in 1 PACKET

NDC Product Information

Sanitizing Hand with NDC 80994-002 is a a human over the counter drug product labeled by Bella Brands Inc. The generic name of Sanitizing Hand is benzethonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Bella Brands Inc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Sanitizing Hand 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.

  • BENZETHONIUM CHLORIDE .1 g/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)
  • ALCOHOL (UNII: 3K9958V90M)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • LICORICE (UNII: 61ZBX54883)
  • CHAMOMILE (UNII: FGL3685T2X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-AMINOBUTYRIC ACID, L- (UNII: 0QAJ5KN9IM)

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.

Labeler Name: Bella Brands Inc
Labeler Code: 80994
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: 05-01-2020 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 - NO 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".

* Please review the disclaimer below.

Sanitizing Hand 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

Other

Drug Facts:

Active Ingredient

Benzethonium Chloride, 0.1%

Purpose

Antimicrobial Agent

Use

For moisturizing hands and decreasing bacteria on the skin.

Warnings

- For external use only.- Do not use if you are allergic to any of the ingredients.- When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water.- Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.

Otc - Keep Out Of Reach Of Children

- Keep out of reach of children. If swallowed, get medical help or visit a Poison Control Center right away.

Inactive Ingredients

Water, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylic/ Capric Triglyceride, Potassium Cetyl Phosphate, Sorbitan Isostearate, Diheptyl Succinate & Capryloyl Glycerin/Sebacic Acid Copolymer, Stearic Acid, Chlorohexidine Gluconate, Carbomer, Polysorbate 20, Aminomethyl Propanol, Tetrasodium EDTA, Camellia Sinensis (Green Tea) ExtractOrganic Ingredient, Glycirrhiza Glabra (Licorice) Root Extract, Aloe Vera Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Phenoxyethanol, Ethylglycerin, Fragrance (Naturally Derived)

Directions For Use

- Press dispensing pump to release product into hands, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry.- For adults and children 2 years and over.- For children under 2 years of age, consult a doctor before use

* Please review the disclaimer below.