FDA.reportPublic FDA data

PVP Iodine

Manufacturer
HART Health | Jiangsu Province JianErKang Medical
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:29:44

Label at a glance#

ProductPVP Iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

First aid topical antiseptic to help prevent infection in: minor cuts scrapes burns abrasions

Dosage and administration

Adults and children 12 years of age and over: apply topically to clean affected area 1 to 3 times daily when dry, may be covered with a sterile bandage if gets in eyes, flush thoroughly with water Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid topical antiseptic to help prevent infection in:

  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or over large portions of the body
  • on serious burns
  • on animal bites
  • on deep or puncture wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 72 hours
  • redness, swelling, irritation or pain occurs

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 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • apply topically to clean affected area 1 to 3 times daily
  • when dry, may be covered with a sterile bandage
  • if gets in eyes, flush thoroughly with water

Children under 12 years of age:

  • ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glyercin, Nonoxynol, Sodium Hydroxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6161PVP100ctv20f.jpg6161PVP100ctv20f.jpg6161PVP100ctv20f.jpg6161PVP100ctv20f.jpg

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
50332-0047-02022-03-09C16284748780-1ba0f9c33-3ec7-a910-e053-dadaa90a0b85PVP IODINE WIPES
50332-0047-72022-03-09C16284748780-1ba0f9c33-3ec7-a910-e053-dadaa90a0b85PVP IODINE WIPES
50332-0047-02021-01-29C16284748780-1ba0f9c33-3ec7-a910-e053-dadaa90a0b85PVP IODINE WIPES
50332-0047-72021-01-29C16284748780-1ba0f9c33-3ec7-a910-e053-dadaa90a0b85PVP IODINE WIPES

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-004750332-0047-0, 50332-0047-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
PVP IodinePOVIDONE-IODINEHART Health06b085dd-934d-40e9-aa0d-2dd9cdccd5352025-12-31WarningsExact identifier
ndc (package): 50332-0047-0
ndc (package): 50332-0047-7
ndc (product): 50332-0047
ndc11 (package): 50332004700
ndc11 (package): 50332004707
spl id: 23a7ffed-6db3-45cf-ac5c-f8366b5dff71
spl set id: 06b085dd-934d-40e9-aa0d-2dd9cdccd535

Reported adverse events (FAERS/openFDA)#

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