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  4. NDC Product Code: 10819-4077 Prevantics Swabstick

NDC 10819-4077 Prevantics Swabstick

Chlorhexidine Gluconate And Isopropyl Alcohol Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 10819-4077?
  4. Prevantics Swabstick Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
10819-4077
Proprietary Name:
Prevantics Swabstick
Non-Proprietary Name: [1]
Chlorhexidine Gluconate And Isopropyl Alcohol
Substance Name: [2]
Chlorhexidine Gluconate; Isopropyl 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]
    Professional Disposables International, Inc.
    Labeler Code:
    10819
    Product Label ID:
    9841200b-d4c6-b40c-e053-2995a90a5596
    FDA Application Number: [6]
    NDA021524
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    06-01-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 10819-4077-2

    Package Description: 500 POUCH in 1 CASE / 1.6 mL in 1 POUCH

    NDC Code 10819-4077-3

    Package Description: 500 POUCH in 1 CASE / 1.6 mL in 1 POUCH

    NDC Code 10819-4077-4

    Package Description: 50 POUCH in 1 BOX / 1.6 mL in 1 POUCH (10819-4077-1)

    Product Details

    What is NDC 10819-4077?

    The NDC code 10819-4077 is assigned by the FDA to the product Prevantics Swabstick which is a human over the counter drug product labeled by Professional Disposables International, Inc.. The generic name of Prevantics Swabstick is chlorhexidine gluconate and isopropyl alcohol. The product's dosage form is solution and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 10819-4077-2 500 pouch in 1 case / 1.6 ml in 1 pouch, 10819-4077-3 500 pouch in 1 case / 1.6 ml in 1 pouch, 10819-4077-4 50 pouch in 1 box / 1.6 ml in 1 pouch (10819-4077-1). 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 Prevantics Swabstick?

    Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.maximum treatment area for one maxi swabstick is approximately: dry site: 4 by 4 inches (10 by 10 cm) or moist site: 3 by 5 inches (7.5 by 12.5 cm)tear open the pouch to expose the swabstickremove the swabstick from package. Do not touch the foam tip.prior to surgery or injection, apply one flat side of foam tip to the proposed skin site and prep the skin in vigorous back-and-forth repeated strokes, turning the swabstick over (unused side of the foam tip) half way in the proceduredry site: scrub repeatedly back and forth for 15 seconds with each side of the applicator for a total of 30 seconds. Allow to air dry for approximately 30 seconds. moist site: scrub repeatedly back and forth for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. do not blot or wipe drydiscard after a single use

    What are Prevantics Swabstick 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 Prevantics Swabstick UNII Codes?

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

    Which are Prevantics Swabstick 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 Prevantics Swabstick?

    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:
    • RxCUI: 1191171 - chlorhexidine gluconate 3.15 % / Isopropyl Alcohol 70 % Medicated Pad
    • RxCUI: 1191171 - chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad
    • RxCUI: 1366736 - Prevantics 3.15 % / 70 % Swabstick
    • RxCUI: 1366736 - chlorhexidine gluconate 31.5 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated Pad [Prevantics]
    • RxCUI: 1366736 - Prevantics (chlorhexidine gluconate 3.15 % / isopropyl alcohol 70 % ) Swabstick

    Which are the Pharmacologic Classes for Prevantics Swabstick?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of 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".