FDA.reportPublic FDA data

Povidone-Iodine

Manufacturer
Medline Industries, LP
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:39:53

Label at a glance#

ProductPovidone-Iodine Swabsticks Singles
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Dosage and administration

Clean the affected area. For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Storage and handling

protect from freezing, avoid excessive heat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, 10.0% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for preparation of the skin prior to surgery
  • 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 one 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

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.
  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other information

STORAGE AND HANDLING SECTION

  • 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.

Manufactured for
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in China
1-800-MEDLINE


REF: MDS093901

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RF22LPDLabel V1 RF22LPD

Tiple Swab Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 3label 3

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
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
53329-945-09Povidone-IodineSwabsticks Singles1 mL in 1 PACKETSWAB18
53329-945-29Povidone-IodineSwabsticks Singles50 in 1 BOXSWAB508
53329-945-29Povidone-IodineSwabsticks Singles1 mL in 1 PACKETSWAB18
53329-946-02Povidone-IodineSwabsticks Triples3 mL in 1 PACKETSWAB38
53329-946-75Povidone-IodineSwabsticks Triples25 in 1 BOXSWAB258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-945-09EA - Each53329-945b37801b4-25aa-4d06-9975-e94b211cb3fe12024-05-16
53329-946-02EA - Each53329-9465a7ce3ac-8285-4f38-acde-a7895688cb2b12019-07-02
53329-946-75EA - Each53329-946a4b6d21b-1b76-4a3e-9702-f8c489de93a712019-07-02

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
53329-94553329-945-29, 53329-945-09
53329-94653329-946-02, 53329-946-75

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-11full-release2026-06-01 00:42:15

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
Povidone-Iodine Swabsticks SinglesPOVIDONE-IODINEMedline Industries, LP28c26a44-0699-4fa5-e054-00144ff88e882025-10-23WarningsExact identifier
ndc (package): 53329-946-02
ndc (package): 53329-946-75
ndc (package): 53329-945-09
ndc (package): 53329-945-29
ndc (product): 53329-945
ndc (product): 53329-946
ndc11 (package): 53329094602
ndc11 (package): 53329094675
ndc11 (package): 53329094509
ndc11 (package): 53329094529
spl id: 41d9ef88-7de7-a717-e063-6394a90a4c29
spl set id: 28c26a44-0699-4fa5-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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