FDA.reportPublic FDA data

povidine iodine

Manufacturer
Dynarex Corporation | Sion Biotext Medical Ltd
Effective date
2013-12-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:37:49

Label at a glance#

Productpovidine iodine
Active ingredientPOVIDONE-IODINE
Label structure12 sections

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                          

Purpose:

OTC - PURPOSE SECTION


Purpose:

  • 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 SECTION

Section Text

  • FOR EXTERNAL USE ONLY

Do not use:

OTC - DO NOT USE SECTION


  • 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 Povidone iodine:

DOSAGE & ADMINISTRATION 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

INDICATIONS & USAGE SECTION

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: nonoxynol-9, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

Povidone iodine.jpg

Povidone iodinePovidone iodine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN8
797730povidone-iodine 100 MG/ML Medicated PadSCD8
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY8
797730povidone-iodine 10 % Medicated PadSY8
797730povidone-iodine 10 % Medicated SwabstickSY8

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
67777-130-012020-01-31C16284748780-19d75b9cf-d9d9-f424-e053-dadaa90a57cePovidone Iodine Swabstick
67777-130-022020-01-31C16284748780-19d75b9cf-d9d9-f424-e053-dadaa90a57cePovidone Iodine Swabstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-130-01povidine iodine0.3 mL in 1 PACKETSWAB0.38
67777-130-01povidine iodine50 in 1 BOXSWAB508
67777-130-02povidine iodine0.9 mL in 1 PACKETSWAB0.98
67777-130-02povidine iodine25 in 1 BOXSWAB258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-130POVIDINE IODINE SWAB [DYNAREX CORPORATION]8Legacy NDC, 4 package rows20131218_40e18738-4357-48e2-8b07-789cf16af640.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-130-01EA - Each67777-13067b09d96-b1d4-4640-8da8-3863565cd08e12022-06-06
67777-130-02EA - Each67777-130963ccb39-bfa4-4e47-8999-ef0689fbde0f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M8
IODINEACTIVE MOIETY9679TC07X48
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T8
WATERINACTIVE INGREDIENT059QF0KO0R8

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
67777-13067777-130-01, 67777-130-02

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-IODINE85H0HZU99MACTIM

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivilog KitMARCAINE, KENALOG, POVIDONE IODINEAsclemed USA, Inc.9d485952-e8f5-4ec9-bab2-6ee4217e807a2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 67777-130-02
ndc11 (package): 67777013002
6e0bb046-ea9e-471b-82aa-815a291dbaef40e18738-4357-48e2-8b07-789cf16af6402013-12-18WarningsExact identifier
spl id: 6e0bb046-ea9e-471b-82aa-815a291dbaef
spl set id: 40e18738-4357-48e2-8b07-789cf16af640

Reported adverse events (FAERS/openFDA)#

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