FDA.reportPublic FDA data

Povidone-Iodine Prep Solution

Manufacturer
O&M HALYARD, INC. | Owens & Minor, Inc
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:25

Label at a glance#

ProductPovidone-Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

Apply locally 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

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

OTC - ASK DOCTOR SECTION

if injuries are • deep or puncture wounds • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

• infection occurs • redness, irritation, swelling or pain persists or increases  

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply locally as needed

Other information

SPL UNCLASSIFIED SECTION

• 1% titratable iodine • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Nonyl nonoxynol-10

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN7
312564povidone-iodine 100 MG/ML Topical SolutionSCD7
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10885632079214GTIN-14: 10885632079214
GTIN storage (14 digits): 10885632079214		Label.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39892-0809-12021-12-08C16284748780-1ba0f9c33-1024-a910-e053-dadaa90a0b85Povidone-Iodine Prep Solution
39892-0809-12021-12-08C16284748780-1ba0f9c33-1024-a910-e053-dadaa90a0b85Povidone-Iodine Prep Solution
39892-0809-12021-01-29C16284748780-1ba0f9c33-1024-a910-e053-dadaa90a0b85Povidone-Iodine Prep Solution
39892-0809-12021-01-29C16284748780-1ba0f9c33-1024-a910-e053-dadaa90a0b85Povidone-Iodine Prep Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0809-1Povidone-Iodine Prep1.5 mL in 1 PACKETSOLUTION1.57

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
39892-080939892-0809-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62023-12-09full-release2026-06-01 00:03:48

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 PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
ndc (package): 39892-0809-1
ndc (product): 39892-0809
ndc11 (package): 39892080901
spl id: 40b3cd7d-5f77-2f44-e063-6294a90a46e0
spl set id: f3e0af11-39b6-44a0-8f84-a4b36631e8f0

Reported adverse events (FAERS/openFDA)#

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