FDA.reportPublic FDA data

Povidone Iodine Prep Solution Sterile

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:20

Label at a glance#

ProductPovidone Iodine Prep Solution Sterile
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Dosage and administration

Apply locally as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Antiseptic skin preparation

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if allergic to iodine
  • in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • infection occurs
  • redness, irritation, swelling or pain persists or increases

Store at room temperature.  Avoid pooling beneath patient Avoid excessive heat.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professinoal assistance or consult a poion control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Apply locally as needed

Other information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Nonyl nonoxynol-10

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN3
312564povidone-iodine 100 MG/ML Topical SolutionSCD3
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY3

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
34645-0013-1Povidone Iodine Prep Solution Sterile30 mL in 1 POUCHSOLUTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0013POVIDONE IODINE PREP SOLUTION STERILE (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 1 package rows20231023_95f8489e-05fa-4f0f-acd6-0c426009080e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-001334645-0013-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
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 Solution SterilePOVIDONE-IODINEJianerkang Medical Co., Ltd95f8489e-05fa-4f0f-acd6-0c426009080e2023-10-23WarningsExact identifier
ndc (package): 34645-0013-1
ndc (product): 34645-0013
ndc11 (package): 34645001301
spl id: 085d0195-7031-e123-e063-6294a90ab344
spl set id: 95f8489e-05fa-4f0f-acd6-0c426009080e

Reported adverse events (FAERS/openFDA)#

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