FDA.reportPublic FDA data

povidine iodine

Manufacturer
Dynarex Corporation
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:25

Label at a glance#

Productpovidine iodine
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Indications and uses

Antiseptic cleanser 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 first.

Storage and handling

Store at room temperature. Avoid excessive heat

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% w/v (9.85% w/w)                     

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Antiseptic cleanser 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

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes.
  • as a first aid antiseptic for more than 1 week.
  • over large areas of the body.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or persists for more than 72 hours
  • Irritation and redness develop

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

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 first.

Other information:

STORAGE AND HANDLING SECTION

  • Store at room temperature.
  • Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, Glycerin, Polysorbate 80 (Tween 80), Sodium Citrate USP, Sodium Phosphate Dibasic, Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Reorder No. 1108

Povidone - Iodine Prep Pads

Antiseptic/Germicide

For External Use Only

dynarex

100 Medium

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN4
797730povidone-iodine 100 MG/ML Medicated PadSCD4
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY4
797730povidone-iodine 10 % Medicated PadSY4
797730povidone-iodine 10 % Medicated SwabstickSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-420-012025-01-30C16284748780-12cef2736-9d13-d83d-e063-dadaa90ab31fPovidone Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-420-01povidine iodine0.3 g in 1 POUCHSWAB0.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-420POVIDINE IODINE SWAB [DYNAREX CORPORATION]4Legacy NDC, 1 package rows20221213_73222b90-6d05-42e2-929c-b5dae5fc1c1d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-420-01EA - Each67777-42082e3c73a-fba8-49ee-989a-9490dafb49a812019-03-12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-42067777-420-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

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
efa768b3-e75b-25a2-e053-2a95a90a4cb773222b90-6d05-42e2-929c-b5dae5fc1c1d2022-12-12WarningsExact identifier
spl id: efa768b3-e75b-25a2-e053-2a95a90a4cb7
spl set id: 73222b90-6d05-42e2-929c-b5dae5fc1c1d

Reported adverse events (FAERS/openFDA)#

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