Prevantics Maxi Swabstick

Prevantics Maxi Swabstick is an FDA-registered drug product whose active ingredient is CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL. It is labelled by Professional Disposables International, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10819-4076, application NDA021524, label effective 20230630. It is one of 4 FDA drug label records sharing the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL are most often described in connection with: patient skin, prior surgery. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 swabstick is approximately 8.4 in. x 8.4 in. (21.3 cm by 21.3 cm). tear open the pouch to expose the swabstick remove 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) halfway in the procedure dry 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 for 1 minute with each side of the applicator for a total of 2 minutes. Allow to air dry for approximately 1.5 minutes. if using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). do not blot or wipe away discard after a single use

Warnings For external use only Flammable, k eep away from fire or flame To reduce the risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow solution to pool remove wet materials from prep area ​​​ Allergy alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If 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 product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under 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.

FDA lists 4 drug label records with CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Prevantics Maxi Swabstick used for?
Use for the preparation of the patient's skin prior to surgery or injection

Who makes Prevantics Maxi Swabstick?
Professional Disposables International, Inc. is the labeler of record for Prevantics Maxi Swabstick. 4 FDA label records share the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Prevantics Maxi Swabstick come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Prevantics Maxi Swabstick prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL?
Yes. 4 FDA drug label records list CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Prevantics Maxi Swabstick been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.