FDA.reportPublic FDA data

Povidone Iodine Prep Pad

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:22

Label at a glance#

ProductPovidone Iodine Prep Pad
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Dosage and administration

Clean the affected area Apply product on the area 1-3 time daily and discard May be covered with a sterile bandage when dry

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

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

OTC - PURPOSE SECTION

Purpose

First Aid Antiseptic

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

For external use only



OTC - DO NOT USE SECTION

Do not

use in the eyes

apply over large areas of the body

use on individuals who are allergic or sensitive to iodine

OTC - STOP USE SECTION

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

OTC - ASK DOCTOR SECTION

Ask a doctor

in case of deep or puncture wounds, animal bites, serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area

Apply product on the area 1-3 time daily and discard

May be covered with a sterile bandage when dry

INACTIVE INGREDIENT SECTION

Inactive Ingredients

citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Pouch label

Pouch Label
Pouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN6
797730povidone-iodine 100 MG/ML Medicated PadSCD6
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY6
797730povidone-iodine 10 % Medicated PadSY6
797730povidone-iodine 10 % Medicated SwabstickSY6

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-4008-3Povidone Iodine Prep Pad0.4 mL in 1 POUCHSWAB0.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4008POVIDONE IODINE PREP PAD (POVIDONE-IODINE) SWAB [JIANERKANG MEDICAL CO., LTD]6Current NDC, Legacy NDC, 1 package rows20231023_be85ec5b-eb49-4f1a-a87d-5c9705a20f23.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
IODINEACTIVE MOIETY9679TC07X42

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
34645-400834645-4008-3

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-10K7O76887APIACT
WATER059QF0KO0RIACT
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-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
ndc (package): 34645-4008-3
ndc (product): 34645-4008
ndc11 (package): 34645400803
spl id: 085b28a4-8db7-0685-e063-6294a90a0d08
spl set id: be85ec5b-eb49-4f1a-a87d-5c9705a20f23

Reported adverse events (FAERS/openFDA)#

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