FDA.reportPublic FDA data

Povidone-Iodine Prep Pad

Manufacturer
Cardinal Health 200, Inc. | Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:57:24

Label at a glance#

ProductPovidone-Iodine Prep Pad
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

• clean the affected area • 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

•first aid to help prevent skin infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only. Do not apply to persons allergic to Iodine Allergy Alert:

Do not use

OTC - DO NOT USE SECTION

• in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns

Stop use and consult a doctor

OTC - STOP USE SECTION

if the condition persists or gets worse

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

• clean the affected area • 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

SPL UNCLASSIFIED SECTION

• store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet Labeling:

Packet LabelPacket Label

Box Labeling:

Box LabelBox Label

Carton Labeling:

Carton LabelingCarton Labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN5
797730povidone-iodine 100 MG/ML Medicated PadSCD5
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY5
797730povidone-iodine 10 % Medicated PadSY5
797730povidone-iodine 10 % Medicated SwabstickSY5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-400-83Povidone-Iodine Prep Pad100 in 1 BOXSOLUTION1005
63517-400-83Povidone-Iodine Prep Pad10 in 1 CARTONSOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-400POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SOLUTION [CARDINAL HEALTH 200, INC.]5Current NDC, Legacy NDC, 2 package rows20231024_06c8a6f6-2fc8-4292-a3b5-6311a918a521.zip

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
63517-40063517-400-83

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
ndc (package): 63517-400-83
ndc (product): 63517-400
ndc11 (package): 63517040083
spl id: 085ebaa7-2663-90e3-e063-6294a90a8a56
spl set id: 06c8a6f6-2fc8-4292-a3b5-6311a918a521

Reported adverse events (FAERS/openFDA)#

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