FDA.reportPublic FDA data

Povidone-Iodine Gel Swabstick

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

Label at a glance#

ProductPovidone-Iodine Gel Swabstick
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

apply product to skin as needed see product box for additional directions

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antispetic

Use

INDICATIONS & USAGE SECTION

Antiseptic Skin Preparation

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

  • If allergic to Iodine
  • in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • Serious burn

Stop use and ask doctor if

OTC - STOP USE SECTION

  • infection occurs
  • redness, irritation or swelling develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply product to skin as needed
  • see product box for additional directions

Other Information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • Avoid excessive heat
  • Store at room temperature
  • For hospital or professional use only
  • Not made with natural rubber latex

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alkyl glucoside, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water

Dukal Povidone-Iodine Gel Swabstick

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itemitemDUKAL™
CORPORATION

NDC 65517-0036-1

REF 899

Hold Upright and Tear Here

POVIDONE-IODINE

Gel Swabstick

Ready Gel 1X™

4" (10.2cm)

Saturated Swabstick

Drug Facts

Active ingredients Purpose
Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation: Helps to

reduce bacterial that potentially can cause skin infection

1/Pouch 2

Made in China D07310901 Rev2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300277povidone-iodine gel 10 % Medicated PadPSN4
1300277povidone-iodine 0.1 MG/MG Medicated PadSCD4
1300277povidone-iodine 10 % (titratable iodine 1 % ) Gel SwabstickSY4
1300277povidone-iodine 10 % Gel SwabstickSY4
1300277povidone-iodine 10 % SwabstickSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130665973007809GTIN-13: 0665973007809
EAN-13: 0665973007809
GTIN-12: 665973007809
UPC-A: 665973007809
GTIN storage (14 digits): 00665973007809		Dukal_899_PVPGelSwab_Item_China_Rev2-01.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
65517-0036-1Povidone-Iodine Gel Swabstick2.3 g in 1 POUCHGEL2.34

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65517-003665517-0036-1

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
WATER059QF0KO0RIACT
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)X70SE62ZARIACT
POTASSIUM IODIDE1C4QK22F9JIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM
NONOXYNOL-10K7O76887APIACT

Source Document#

Source XML · Source PDF

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
Povidone-Iodine Gel SwabstickPOVIDONE IODINEDukal LLC98be29e6-0c9b-22a6-e053-2995a90a9f8c2025-11-19WarningsExact identifier
ndc (package): 65517-0036-1
ndc (product): 65517-0036
ndc11 (package): 65517003601
spl id: 43f8fa99-4702-1636-e063-6294a90a6028
spl set id: 98be29e6-0c9b-22a6-e053-2995a90a9f8c

Reported adverse events (FAERS/openFDA)#

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