NDC 50865-688 Ezfoam Foaming Alcohol Hand Sanitizer

Foaming Hand Sanitizer Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
50865-688
Proprietary Name:
Ezfoam Foaming Alcohol Hand Sanitizer
Non-Proprietary Name: [1]
Foaming Hand Sanitizer
Substance Name: [2]
Alcohol
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Kutol Products Company
    Labeler Code:
    50865
    FDA Application Number: [6]
    part333A
    Marketing Category: [8]
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date: [9]
    06-27-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 50865-688-09

    Package Description: 3785 mL in 1 JUG

    NDC Code 50865-688-17

    Package Description: 50 mL in 1 BOTTLE, PLASTIC

    NDC Code 50865-688-24

    Package Description: 1000 mL in 1 BAG

    NDC Code 50865-688-41

    Package Description: 1000 mL in 1 BAG

    NDC Code 50865-688-50

    Package Description: 1200 mL in 1 BAG

    NDC Code 50865-688-78

    Package Description: 950 mL in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 50865-688?

    The NDC code 50865-688 is assigned by the FDA to the product Ezfoam Foaming Alcohol Hand Sanitizer which is a human over the counter drug product labeled by Kutol Products Company. The generic name of Ezfoam Foaming Alcohol Hand Sanitizer is foaming hand sanitizer. The product's dosage form is solution and is administered via topical form. The product is distributed in 6 packages with assigned NDC codes 50865-688-09 3785 ml in 1 jug , 50865-688-17 50 ml in 1 bottle, plastic , 50865-688-24 1000 ml in 1 bag , 50865-688-41 1000 ml in 1 bag , 50865-688-50 1200 ml in 1 bag , 50865-688-78 950 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Ezfoam Foaming Alcohol Hand Sanitizer?

    Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.Avoid contact with eyes. If eye contact occurs, flush with water.Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.Keep out of reach of children. If swallowed, contact a physician or poison control center.

    What are Ezfoam Foaming Alcohol Hand Sanitizer Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Ezfoam Foaming Alcohol Hand Sanitizer UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Ezfoam Foaming Alcohol Hand Sanitizer Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Ezfoam Foaming Alcohol Hand Sanitizer?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".