NDC 80948-011 Puroma Hand Sanitizer Wipe Alcohol Free

Benzalkonium Chloride Cloth Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
80948-011
Proprietary Name:
Puroma Hand Sanitizer Wipe Alcohol Free
Non-Proprietary Name: [1]
Benzalkonium Chloride
Substance Name: [2]
Benzalkonium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
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]
    Zenith Micro Control
    Labeler Code:
    80948
    FDA Application Number: [6]
    M003
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    03-12-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 80948-011-01

    Package Description: 10 PACKAGE in 1 PACKAGE / 66 mL in 1 PACKAGE

    NDC Code 80948-011-02

    Package Description: 20 PACKAGE in 1 PACKAGE / 132 mL in 1 PACKAGE

    NDC Code 80948-011-03

    Package Description: 40 PACKAGE in 1 PACKAGE / 264 mL in 1 PACKAGE

    NDC Code 80948-011-04

    Package Description: 80 PACKAGE in 1 PACKAGE / 528 mL in 1 PACKAGE

    NDC Code 80948-011-05

    Package Description: 120 PACKAGE in 1 PACKAGE / 792 mL in 1 PACKAGE

    NDC Code 80948-011-06

    Package Description: 50 CANISTER in 1 CANISTER / 350 mL in 1 CANISTER

    NDC Code 80948-011-07

    Package Description: 100 CANISTER in 1 CANISTER / 700 mL in 1 CANISTER

    Product Details

    What is NDC 80948-011?

    The NDC code 80948-011 is assigned by the FDA to the product Puroma Hand Sanitizer Wipe Alcohol Free which is a human over the counter drug product labeled by Zenith Micro Control. The generic name of Puroma Hand Sanitizer Wipe Alcohol Free is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form. The product is distributed in 7 packages with assigned NDC codes 80948-011-01 10 package in 1 package / 66 ml in 1 package, 80948-011-02 20 package in 1 package / 132 ml in 1 package, 80948-011-03 40 package in 1 package / 264 ml in 1 package, 80948-011-04 80 package in 1 package / 528 ml in 1 package, 80948-011-05 120 package in 1 package / 792 ml in 1 package, 80948-011-06 50 canister in 1 canister / 350 ml in 1 canister, 80948-011-07 100 canister in 1 canister / 700 ml in 1 canister. 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 Puroma Hand Sanitizer Wipe Alcohol Free?

    Pull out one sheet from the pack. Clean hands or affected area.Discard wipes in trash receptacle after use.Do not flush.Close lid after each used to keep wipes fresh.

    What are Puroma Hand Sanitizer Wipe Alcohol Free 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 Puroma Hand Sanitizer Wipe Alcohol Free UNII Codes?

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

    Which are Puroma Hand Sanitizer Wipe Alcohol Free 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 Puroma Hand Sanitizer Wipe Alcohol Free?

    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:

    * Please review the disclaimer below.

    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".