FDA.reportPublic FDA data

Povidone-Iodine

Manufacturer
Medline Industries, LP
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:39:53

Label at a glance#

ProductPovidone-Iodine Prep Pads Medium
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Indications and uses

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

clean the affected area apply a small amount of this product on the area 1 to 3 times daily. may be covered with a sterile bandage if bandaged, let dry first

Storage and handling

do not flush protect from freezing, avoid excessive heat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine USP, 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical assistance or immediately contact a Poison Control Center.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily.
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

STORAGE AND HANDLING SECTION

  • do not flush
  • protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, purified water

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

©2017 Medline Industries, LP. Medline is a registered

trademark of Medline Industries, LP. Made in China for:

Medline Industries, LP, Three Lakes Drive, Northfield,

IL 60093 USA. 1-800-MEDLINE

REF: MDS093917

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet LabelPacket LabelBox LabelBox Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN10
797730povidone-iodine 100 MG/ML Medicated PadSCD10
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY10
797730povidone-iodine 10 % Medicated PadSY10
797730povidone-iodine 10 % Medicated SwabstickSY10

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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-940-09Povidone-IodinePrep Pads Medium Bulk1 mL in 1 PACKETCLOTH110
53329-940-97Povidone-IodinePrep Pads Medium Bulk3000 in 1 CASECLOTH300010
53329-940-97Povidone-IodinePrep Pads Medium Bulk1 mL in 1 PACKETCLOTH110
53329-941-09Povidone-IodinePrep Pads Medium1 mL in 1 PACKETCLOTH110
53329-941-30Povidone-IodinePrep Pads Medium100 in 1 BOXCLOTH10010

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-94153329-941-09, 53329-941-30
53329-94053329-940-97, 53329-940-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-12-10full-release2026-06-01 00:41:50

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Physician EZ Use Joint Tunnel and Trigger Kit IILIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINEAsclemed USA, Inc.0d2d52ef-ff21-4b28-b8ae-6a46570f7a742026-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 53329-941-30
ndc11 (package): 53329094130
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
ndc (package): 53329-941-09
ndc (package): 53329-940-09
ndc (package): 53329-940-97
ndc (package): 53329-941-30
ndc (product): 53329-941
ndc (product): 53329-940
ndc11 (package): 53329094130
ndc11 (package): 53329094009
ndc11 (package): 53329094109
ndc11 (package): 53329094097
spl id: 41d5b217-3e40-1229-e063-6394a90ae37c
spl set id: 28c05c5c-09d3-2c62-e054-00144ff8d46c
Physician EZ Use Joint Tunnel and Trigger KitAMMONIA, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINEAsclemed USA, Inc.e25cfc22-29ba-473f-88c4-3c88e9f6863b2024-10-05Warnings, Adverse reactionsExact identifier
ndc (package): 53329-941-30
ndc11 (package): 53329094130

Reported adverse events (FAERS/openFDA)#

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