povidine iodine

Manufacturer
Dynarex Corporation | Sion Biotext Medical Ltd
Effective date
2010-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:29

Label at a glance#

Productpovidine iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

Section Text First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infections.

Dosage and administration

Tear at notch, remove applicator, use only once. As a first aid antiseptic clean affected area apply 1 to 3 times daily may be covered with a sterile bandage, if bandaged let dry. For preoperative patient skin preparation clean area apply to operative site prior to surgery using the applicator

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Section Text

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses:

OTC - PURPOSE SECTION


Section Text

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Warnings:

WARNINGS AND PRECAUTIONS SECTION

Section Text

  • FOR EXTERNAL USE ONLY

Do not use:

OTC - DO NOT USE SECTION

Section Text


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use:

OTC - STOP USE SECTION

  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

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.

Directions:

SPL UNCLASSIFIED SECTION

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

  • clean area
  • apply to operative site prior to surgery using the applicator

Other information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Avoid excessive heat

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Povidone_iodinePovidone_iodine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN1
797730povidone-iodine 100 MG/ML Medicated PadSCD1
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY1
797730povidone-iodine 10 % Medicated PadSY1
797730povidone-iodine 10 % Medicated SwabstickSY1

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
67777-140-012020-01-31C16284748780-19d75b9d0-d3c9-f424-e053-dadaa90a57cePovidone Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-140-01povidine iodine100 in 1 BOXSWAB1001
67777-140-01povidine iodine10 in 1 CASESWAB101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-140POVIDINE IODINE SWAB [DYNAREX CORPORATION]1Legacy NDC, 2 package rows20100511_e39ef99d-c778-4862-9d93-4074753c47ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-140-01EA - Each67777-14048558a57-e273-46c7-874c-73e62d2e32a812018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
POVIDONE-IODINEACTIVE MOIETY85H0HZU99M1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-14067777-140-01

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
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates

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
56609c63-de60-4111-a317-4f0fc1db502be39ef99d-c778-4862-9d93-4074753c47ad2010-05-10WarningsExact identifier
spl id: 56609c63-de60-4111-a317-4f0fc1db502b
spl set id: e39ef99d-c778-4862-9d93-4074753c47ad

Reported adverse events (FAERS/openFDA)#

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