FDA.reportPublic FDA data

Povidone-Iodine Gel

Manufacturer
Dukal LLC
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:03

Label at a glance#

ProductPovidone-Iodine Gel
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Dosage and administration

apply product to skin as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Patient preoperative skin preparation. Helps to reduce bacteria that potentially can cause skin infection.

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

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

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, Citric Acid, Glycerin, Hydroxyethyl Cellulose, Nonoxynol-10, Potassium Iodide, Sodium hydroxide, Water

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Duka

Povidone-Iodine

Gel

Non-Sterile

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

1 fl oz (29.5ml) Do not re-use NDC-66517-0070-1 REF 916

916916

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)10665973032372GTIN-14: 10665973032372
GTIN storage (14 digits): 10665973032372		916_Povidone-Iodine-Gel_Item_China.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-0070-1Povidone-Iodine Gel29.5 mL in 1 POUCHGEL29.52

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
65517-007065517-0070-1

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
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
POTASSIUM IODIDE1C4QK22F9JIACT

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
Povidone-Iodine GelPOVIDONE-IODINEDukal LLC2bebe082-59b6-17c1-e063-6294a90a9a522025-11-19WarningsExact identifier
ndc (package): 65517-0070-1
ndc (product): 65517-0070
ndc11 (package): 65517007001
spl id: 43f8fa10-9266-a4f3-e063-6394a90a9e93
spl set id: 2bebe082-59b6-17c1-e063-6294a90a9a52

Reported adverse events (FAERS/openFDA)#

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