FDA.reportPublic FDA data

Povidone-Iodine

Manufacturer
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
Effective date
2011-07-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:28:31

Label at a glance#

ProductPovidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure6 sections

Dosage and administration

Wipe injection site vigorously and discard.

Label contents#

Full prescribing information#

Use

INDICATIONS & USAGE SECTION

Antiseptic for preparation of skin.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Cautions

WARNINGS SECTION

For External Use Only.
Do not use:
Apply over large areas of the body, use in the eyes
Drug Facts (continued):
Stop use and ask a doctor if irritation and redness develops.
If condition persists for more than 72 hours, consult a physician.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature, 59º-86ºF(15º-30℃), avoid excessive heat.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% w/v (equivalent to 1%iodine)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here397397

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN2
797730povidone-iodine 100 MG/ML Medicated PadSCD2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY2
797730povidone-iodine 10 % Medicated PadSY2
797730povidone-iodine 10 % Medicated SwabstickSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POVIDONE-IODINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35617-397-012019-10-29C16284748780-1960f7f55-cbc0-8e05-e053-dbdaa90a074aDrug Fact Povidone-Iodine Swabsticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35617-397-01Povidone-Iodine1 in 1 PACKAGESWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35617-397POVIDONE-IODINE SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]2Legacy NDC, 1 package rows20110706_117aa16f-f83d-44dd-9c03-c141f6283c1f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
POVIDONE-IODINEACTIVE MOIETY85H0HZU99M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35617-39735617-397-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIB
WATER059QF0KO0RIACT

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
9bea2c38-9eac-4b4d-b28f-cebf3de14d88117aa16f-f83d-44dd-9c03-c141f6283c1f2011-07-05WarningsExact identifier
spl id: 9bea2c38-9eac-4b4d-b28f-cebf3de14d88
spl set id: 117aa16f-f83d-44dd-9c03-c141f6283c1f

Reported adverse events (FAERS/openFDA)#

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