PVP-I Prep Pads paper-foil

Manufacturer: Dukal LLC
Effective date: 2025-11-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:17:28

Label at a glance#

ProductPVP-I Prep Pads paper-foil

Active ingredientPOVIDONE-IODINE

Label structure9 sections

Dosage and administration

Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP 10%

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

Warnings:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not apply to persons allergic to iodine. Do not use in the eyes.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

Other Information:

OTHER SAFETY INFORMATION

1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

Principal Display Panel - PVP-I Prep Pads Paper/Foil Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dukal

Povidone-Iodine

Prep Pad

Non-Sterile

Antiseptic

For Professional and Hospital Use

Not Made with Natural Rubber Latex

Manufactured For: Dukal LLC

1(800)243-0741 / Ronkonkoma, NY 11779

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch / 2 / NDC 65517-0039-1 / REF 914

914 Item

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65517-0039-1	PVP-I Prep Pads paper-foil	0.5 mL in 1 APPLICATOR	SWAB	0.5		4
65517-0039-1	PVP-I Prep Pads paper-foil	1 in 1 POUCH	SWAB	1		4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

PVP-I Prep Pads paper-foil
Povidone-iodine
GLYCERIN
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)
NONOXYNOL-10
ANHYDROUS CITRIC ACID
SODIUM HYDROXIDE
WATER
C12-20 ALKYL GLUCOSIDE
POTASSIUM IODIDE
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65517-0039	65517-0039-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	S38J6RZN16	IACT
NONOXYNOL-10	K7O76887AP	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
C12-20 ALKYL GLUCOSIDE	K67N5Z1RUA	IACT
POTASSIUM IODIDE	1C4QK22F9J	IACT
POVIDONE-IODINE	85H0HZU99M	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PVP-I Prep Pads paper-foil	POVIDONE-IODINE	Dukal LLC	f4596b0c-0e04-d71a-e053-2995a90a3b20	2025-11-19	Warnings	Exact identifier ndc (package): 65517-0039-1 ndc (product): 65517-0039 ndc11 (package): 65517003901 spl id: 43f8ffc3-adc4-a8e3-e063-6394a90ad682 spl set id: f4596b0c-0e04-d71a-e053-2995a90a3b20

Reported adverse events (FAERS/openFDA)#

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