Prevantics Swab
Prevantics Swab is an FDA drug label for the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL manufactured by Professional Disposables International, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231013.
- Generic name
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Manufacturer
- Professional Disposables International, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 10819-1080
- Application
- NDA021524
- Label effective
- 20231013
About this product
Prevantics Swab 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 10819-1080, application NDA021524, label effective 20231013. 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.
What it is used for
Across FDA labelling, products containing CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL are most often described in connection with: patient skin, prior injection. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use for the preparation of the patient's skin prior to an injection
Dosage & Administration
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 swab is approximately 2.5 by 2.5 inches (6 by 6 cm) tear open packet and remove swab. Do not unfold swab. prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds. allow the prepped area to air dry for 30 seconds do not blot or wipe dry discard after a single use
Warnings
Warnings For external use only Flammable, keep away from fire or flame Do not use with electrocautery procedures 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.
More products with the same ingredient
CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLHow products containing CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL compare
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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Professional Disposables International, Inc. | 3 |
| — | — | Solventum US LLC | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0572-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. | Professional Disposables International, Inc. | Class II | Terminated | 20220302 |
| D-0571-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. | Professional Disposables International, Inc. | Class II | Terminated | 20220302 |
| D-0570-2022 | Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. | Professional Disposables International, Inc. | Class II | Terminated | 20220302 |
Frequently asked questions
What is Prevantics Swab used for?
Use for the preparation of the patient's skin prior to an injection
Who makes Prevantics Swab?
Professional Disposables International, Inc. is the labeler of record for Prevantics Swab. 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 Swab 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 Swab 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 Swab 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.