Prevantics Maxi Swabstick Solution
NDC 10819-4076
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Prevantics Maxi Swabstick (chlorhexidine gluconate and isopropyl alcohol) is a NDA-approved product labeled by Professional Disposables International, Inc.. This medication is typically used as a decreased cell wall integrity [pe]. It is supplied as a solution for topical administration. This product entry covers the primary NDC 10819-4076 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
10819-4076
Proprietary Name:
Prevantics Maxi 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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
10819
Product Label ID:
FDA Application Number: [6]
NDA021524
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-01-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 10819-4076?
The NDC code 10819-4076 is assigned by the FDA to the product Prevantics Maxi Swabstick. It is commonly known by its generic name, chlorhexidine gluconate and isopropyl alcohol. This pharmaceutical product is labeled by Professional Disposables International, Inc. and is currently categorized as listed product. The medication is a solution administered via topical route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 10819-4076-3, 10819-4076-3, 10819-4076-4, 10819-4076-4. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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: 7 by 7 inches (18 by 18 cm) or moist site: 3 by 7.5 inches (7.5 by 19 cm)open the pouch to expose the swabstickremove 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) hlf 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 Active Ingredients of this product?
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 the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
- CHLORHEXIDINE (UNII: R4KO0DY52L) (Active Moiety)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- ISOPROPYL ALCOHOL (UNII: ND2M416302) (Active Moiety)
Which are the Inactive Ingredients associated 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:
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
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 of this product?
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.
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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
