PVP Iodine Prep Pad Medium and Large
PVP Iodine Prep Pad Medium and Large is an FDA drug label for the active ingredient PROVIDONE IODINE 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 20260731.
- Generic name
- PROVIDONE IODINE
- Manufacturer
- Professional Disposables International, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 10819-3883
- Application
- 505G(a)(3)
- Label effective
- 20260731
About this product
PVP Iodine Prep Pad Medium and Large is an FDA-registered drug product whose active ingredient is PROVIDONE IODINE. It is labelled by Professional Disposables International, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10819-3883, application 505G(a)(3), label effective 20260731. 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 PROVIDONE IODINE are most often described in connection with: broad spectrum, topical application, skin prior. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
Dosage & Administration
Directions For preparation of the skin prior to surgery clean the treatment area remove swab apply to the operative site prior to surgery allow to dry
Warnings
Warnings For external use only If swallowed, get medical help or contact a Poison Control Center. Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider
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 PVP Iodine Prep Pad Medium and Large used for?
Uses A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
Who makes PVP Iodine Prep Pad Medium and Large?
Professional Disposables International, Inc. is the labeler of record for PVP Iodine Prep Pad Medium and Large.
What form does PVP Iodine Prep Pad Medium and Large 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 PVP Iodine Prep Pad Medium and Large 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.
Has PVP Iodine Prep Pad Medium and Large 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.