NDC 77032-0003 Ez Groom Hand Sanitizing Wipes

Bzk Hand Sanitizing Wipes

NDC Product Code 77032-0003

NDC 77032-0003-1

Package Description: 100 mL in 1 CANISTER

NDC Product Information

Ez Groom Hand Sanitizing Wipes with NDC 77032-0003 is a a human over the counter drug product labeled by Ez-groom. The generic name of Ez Groom Hand Sanitizing Wipes is bzk hand sanitizing wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Ez-groom

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Ez Groom Hand Sanitizing Wipes 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.

  • 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: Ez-groom
Labeler Code: 77032
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: 10-01-2020 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.

Ez Groom Hand Sanitizing Wipes Product Label Images

Ez Groom Hand Sanitizing Wipes 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 Purpose

Benzalkonium Chloride 0.13% Purpose Antimicrobial Agent

Purpose

Antibacterial Hand Wipes

Indications And Use

Hand sanitizing wipes to help reduce bacterial that can potentially cause disease. For use when soap and water are not available.

Warnings

For external use only.Do not use if you are allergic to any of the ingredientsWhen using product do not get into eyes. If contact occurs, rinse thoroughly with waterStop use and see a doctor if irritation or rash develops and continues for more than 72 hoursKeep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water, Alcohol Denat, Phenoxyethanol, PEG-8 Dimethicone, Caprylyl, Glycol, Dihydroxypropyl PEG-5, Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

Manufactured And Distributed By

EZ Groom ProductsOak Park, Michigan

Dosage

Use towel to thoroughly moisten hands. Discard towel in a waste container.

* Please review the disclaimer below.