NDC 10819-4077 Prevantics Swabstick

Chlorhexidine Gluconate And Isopropyl Alcohol

NDC Product Code 10819-4077

NDC CODE: 10819-4077

Proprietary Name: Prevantics Swabstick What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Chlorhexidine Gluconate And Isopropyl Alcohol 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

NDC Code Structure

NDC 10819-4077-2

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

NDC 10819-4077-3

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

NDC 10819-4077-4

Package Description: 50 POUCH in 1 BOX > 1.6 mL in 1 POUCH

NDC Product Information

Prevantics Swabstick with NDC 10819-4077 is a 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.

Labeler Name: Professional Disposables International, Inc.

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.

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.

Prevantics Swabstick 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.

  • CHLORHEXIDINE GLUCONATE 31.5 mg/mL
  • ISOPROPYL ALCOHOL .7 mL/mL

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: Professional Disposables International, Inc.
Labeler Code: 10819
FDA Application Number: NDA021524 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: NDA - A product marketed under an approved New Drug Application. 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: 06-01-2020 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.

Prevantics Swabstick Product Label Images

Prevantics Swabstick 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 Ingredients

Chlorhexidine gluconate 3.15% w/vIsopropyl alcohol 70% v/v

Purposes

AntisepticAntiseptic

Use

For the preparation of the patient's skin prior to surgery or injection

Warnings

  • For external use onlyFlammable, keep away from fire or flameDo not use with electrocautery procedures

Allergy Alert

  • This product may cause a severe allergic reaction. Symptoms may include:wheezing/difficulty breathingshockfacial swellinghivesrashIf an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

  • On patients allergic to chlorhexidine gluconate or any other ingredient in this productfor lumbar puncture or in contact with the meningeson open skin wounds or as a general skin cleanserunder occlusive patch

When Using This Product

Keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain.If contact occurs, rinse with cold water right away and contact a doctor.

Stop Use And Ask A Doctor If

Irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

Other Information

  • Store between 68-77°F (20-25°C)avoid freezing and excessive heat above 104°F (40°C)for hospital and professional use only

Inactive Ingredients

USP purified water

* Please review the disclaimer below.