FDA.reportPublic FDA data

Povidone Iodine Prep

Manufacturer
MCL Enterprises
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:51

Label at a glance#

ProductPovidone Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure6 sections

Dosage and administration

Clean the treatment area Apply a small amout of this product on the area 1~3 times daily  may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

  • For preparation of the skin prior to surgery 
  • First aid antiseptic to help prevent infection in scrapes, minor cuts and burns

Warnings:

WARNINGS SECTION

  • For external use only

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.

Do not use:

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body 
  • longer than 1 week unless directed by a doctor 
  • on individuals who are sensitive or allergic to iodine

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • if irritation and redness develop. 
  • condition persists more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean the treatment area
  • Apply a small amout of this product on the area 1~3 times daily 
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
71622-003-002020-09-27C16284748780-1ab0e2407-2fdb-f274-e053-dbdaa90a6471Povidone-Iodine Prep Pad
71622-003-002020-09-25C16284748780-1ab0e2407-2fdb-f274-e053-dbdaa90a6471Povidone-Iodine Prep Pad
71622-003-002020-07-22C16284748780-1ab0e2407-2fdb-f274-e053-dbdaa90a6471Povidone-Iodine Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71622-003-00Povidone Iodine Prep0.45 g in 1 PATCHPATCH0.452
71622-003-00Povidone Iodine Prep1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71622-003POVIDONE IODINE PREP (POVIDONE-IODINE) PATCH [MCL ENTERPRISES]2Legacy NDC, 2 package rows20171229_eca6e2ce-bb1e-4954-b384-753cb295c704.zip

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
71622-00371622-003-00

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-IODINE85H0HZU99MACTIM
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
616db97b-6da1-21c0-e053-2991aa0ab688eca6e2ce-bb1e-4954-b384-753cb295c7042017-12-28WarningsExact identifier
spl id: 616db97b-6da1-21c0-e053-2991aa0ab688
spl set id: eca6e2ce-bb1e-4954-b384-753cb295c704

Reported adverse events (FAERS/openFDA)#

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