FDA.reportPublic FDA data

PVP-Iodine Swabstick Threes

Manufacturer
Dukal LLC
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:17:13

Label at a glance#

ProductPVP-Iodine Swabstick Threes
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

Clean the area. Apply product to the operative site prior to surgery using sponge sticks 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.

  • 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 sponge sticks 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 Swabstick Sterile 883 Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883

883883

Principal Display Panel - PVP-I Prep Swabstick Sterile 884 Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

1 Per Pouch - 2 - NDC 6551-0033-1 - REF 884

884884

Principal Display Panel - PVP-I Prep Swabstick Sterile 883C Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883C

883C883C

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN9
797730povidone-iodine 100 MG/ML Medicated PadSCD9
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY9
797730povidone-iodine 10 % Medicated PadSY9
797730povidone-iodine 10 % Medicated SwabstickSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10665973024988GTIN-14: 10665973024988
GTIN storage (14 digits): 10665973024988		883_PVP Swabsticks_Item_China_OL.jpg
BarcodeCode 128(01)10665973028870GTIN-14: 10665973028870
GTIN storage (14 digits): 10665973028870		883C_PVP-Swabsticks_Item_China.jpg
BarcodeData Matrix(01)10665973025008GTIN-14: 10665973025008
GTIN storage (14 digits): 10665973025008		884_PVP Swabsticks_Item_China_OL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-0033-1PVP-Iodine Swabstick Threes1 in 1 POUCHSWAB19
65517-0033-1PVP-Iodine Swabstick Threes1000 in 1 CASESWAB10009
65517-0033-3PVP-Iodine Swabstick Threes3 in 1 POUCHSWAB39
65517-0033-3PVP-Iodine Swabstick Threes500 in 1 CASESWAB5009

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65517-003365517-0033-1, 65517-0033-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
NONOXYNOL-10K7O76887APIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POTASSIUM IODIDE1C4QK22F9JIACT
POVIDONE-IODINE85H0HZU99MACTIM

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-Iodine Swabstick ThreesPOVIDONE-IODINEDukal LLC5af20b49-11b1-4b15-bb7f-eccda2c469972025-11-19WarningsExact identifier
ndc (package): 65517-0033-3
ndc (package): 65517-0033-1
ndc (product): 65517-0033
ndc11 (package): 65517003303
ndc11 (package): 65517003301
spl id: 43f8dcdb-1cc7-7f1d-e063-6394a90ad1b6
spl set id: 5af20b49-11b1-4b15-bb7f-eccda2c46997

Reported adverse events (FAERS/openFDA)#

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