FDA.reportPublic FDA data

PVP-I Prep Pads

Manufacturer
Professional Disposables International, Inc.
Effective date
2026-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:33:18

Label at a glance#

ProductPVP-I Prep Pad
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

A broad spectrum antiseptic for topical application for preparation of skin prior to surgery.

Dosage and administration

Tear at notch Clean the treatment area Remove swab Apply to the operative site prior to surgery Allow to dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • A broad spectrum antiseptic for topical application for preparation of skin prior to surgery.

Warnings

WARNINGS SECTION

For external use only

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear at notch
  • Clean the treatment area
  • Remove swab
  • Apply to the operative site prior to surgery
  • Allow to dry

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide

Do not use

OTC - DO NOT USE SECTION

Do not use

- in the eyes, nose or mouth
- on individuals who are allergic or sensitive to iodine
- over large areas of the body

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet 10819-3801-1

packetpacket

Box 10819-3801-2

boxbox

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00310819000147GTIN-14: 00310819000147
GTIN-12: 310819000147
UPC-A: 310819000147
EAN-13: 0310819000147
GTIN storage (14 digits): 00310819000147		2NB406 packet.jpg
BarcodeCode 128(01)10310819000144GTIN-14: 10310819000144
GTIN storage (14 digits): 10310819000144		5RB40600 box.jpg
Data codeData Matrix2NB4062NB406 packet.jpg
Data codeData Matrix5RB406005RB40600 box.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10819-380110819-3801-1, 10819-3801-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-10K7O76887APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsExact identifier
ndc (package): 10819-3801-1
ndc (package): 10819-3801-2
ndc (product): 10819-3801
ndc11 (package): 10819380101
ndc11 (package): 10819380102
spl id: 57b02ea2-7b36-0b77-e063-6394a90acff5
spl set id: 57b02fbb-a9a6-0b8c-e063-6394a90a44f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.