NDC 66949-106 Zep Fuzion Antimicrobial Hand Cleaner

Benzalkonium Chloride

NDC Product Code 66949-106

NDC 66949-106-16

Package Description: 4800 mL in 1 CASE

NDC Product Information

Zep Fuzion Antimicrobial Hand Cleaner with NDC 66949-106 is a a human over the counter drug product labeled by Zep Inc.. The generic name of Zep Fuzion Antimicrobial Hand Cleaner is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Zep Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Zep Fuzion Antimicrobial Hand Cleaner 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 .13 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.

  • MAGNESIUM (UNII: I38ZP9992A)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)
  • CUPRIC NITRATE (UNII: 9TC879S2ZV)
  • ALCOHOL (UNII: 3K9958V90M)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • MYRISTAMINE OXIDE (UNII: J086PM3RRT)
  • DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)

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: Zep Inc.
Labeler Code: 66949
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: 06-01-2020 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.

Zep Fuzion Antimicrobial Hand Cleaner Product Label Images

Zep Fuzion Antimicrobial Hand Cleaner 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

Antiseptic Hand Wash

Uses

  • Hand washing to decrease bacteria on skin.For use in food processing facilities.

Warnings

For external use only.Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

When Using This Product

  • Do not swallow.If swallowed, do not induce vomiting and if individual is conscious, give large quantities of water to drink and consult a physician immediately.

Stop Use And Ask A Doctor

Stop use and ask a doctor if skin irritation or redness persists for more than 72 hours.

Keep Out Of Reach Of Children And Pets

Keep out of reach of children and pets. Children must be supervised in use of this product.

Directions

  • Wet hands with water.Place hands under dispenser and apply liquid soap.Massage soap into hands and wrists, emphasizing back of hands, knuckles, and cuticles.Rinse hands thoroughly and dry.

Other Information

  • Store at 20 to 25°C (68 to 77°F).Do not freeze.Dispose in accordance with all applicable federal, state and local regulations.

Inactive Ingredients

Water, Didecyldimethylammonium Chloride, Cocamidopropyl Hydroxysultaine, Lauramine Oxide, PEG-6 Cocamide, Hydroxyethyl Cellulose, Phenoxyethanol, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Hexanediol, Citric Acid, Sodium Citrate

* Please review the disclaimer below.