FDA.reportPublic FDA data

POVIDONE IODINE PREP PAD Sterile

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:21

Label at a glance#

ProductPOVIDONE IODINE PREP PAD Sterile
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

Clean the affected area Apply the product on the area and discard May be covered with a sterile bandage when dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

  • use in the eyes
  • apply over large over large areas of the body
  • use on individuals who are allergic or sensitive to iodine. 

Stop use and consult a doctor

OTC - STOP USE SECTION

  • if the condition persists or gets worse
  • for use longer than 1 week.

Ask a doctor 

OTC - ASK DOCTOR SECTION

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

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 the product on the area and discard
  • May be covered with a sterile bandage when dry.

Other information

SPL UNCLASSIFIED SECTION

  • Avoid excessive heat.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, alkyl glucoside, hydroxyethyl cellulose, nonoxynol-10, glycerin, sodium hydroxide, potassium iodide, purified water

Package Labeling:0.4ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN2
797730povidone-iodine 100 MG/ML Medicated PadSCD2
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY2
797730povidone-iodine 10 % Medicated PadSY2
797730povidone-iodine 10 % Medicated SwabstickSY2

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
34645-0022-0POVIDONE IODINE PREP PAD Sterile1 in 1 POUCHCLOTH12
34645-0022-0POVIDONE IODINE PREP PAD Sterile0.4 mL in 1 PATCHCLOTH0.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0022POVIDONE IODINE PREP PAD STERILE (POVIDONE-IODINE) CLOTH [JIANERKANG MEDICAL CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231023_ac3aa401-a124-4eb7-9598-119be0f24ddd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-002234645-0022-0

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
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 PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
ndc (package): 34645-0022-0
ndc (product): 34645-0022
ndc11 (package): 34645002200
spl id: 085ce5e1-bafc-a353-e063-6394a90a5721
spl set id: ac3aa401-a124-4eb7-9598-119be0f24ddd

Reported adverse events (FAERS/openFDA)#

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