FDA.reportPublic FDA data

Povidone Iodine Topical Solution Paint

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:18

Label at a glance#

ProductPovidone Iodine Topical Solution Paint
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Dosage and administration

Patient preoperative prep apply solution to operative site following povidone iodine scrub application using a circular motion, start at incision site and move outward remove all soiled underdrapes do no allow solution to pool

Storage and handling

store at room temperature avoid excessive heat (above 104 degrees F/40 degrees C) protect from freezing latex free

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, USP 10%

(1.0% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

prepping intact skin and mucous membranes prior to sugery

Warnings

WARNINGS SECTION

for external use only

avoid use on persons allergic to iodine

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

  • skin shows symptoms of irritation, sensitivity, redness, pain or swelling

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

Patient preoperative prep

  • apply solution to operative site following povidone iodine scrub application
  • using a circular motion, start at incision site and move outward
  • remove all soiled underdrapes
  • do no allow solution to pool

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • avoid excessive heat (above 104 degrees F/40 degrees C)
  • protect from freezing
  • latex free

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, glycerol, nonylphenol ethoxylate, Purified Water, sodium hydroxide

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN4
312564povidone-iodine 100 MG/ML Topical SolutionSCD4
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY4

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
34645-1041-1Povidone Iodine Topical Solution Paint88.5 mL in 1 BOTTLELIQUID88.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-1041POVIDONE IODINE TOPICAL SOLUTION PAINT (POVIDONE IODINE 10%) LIQUID [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 1 package rows20231023_42778607-6170-4a5e-94d0-5e6cd064eec6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AU1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-104134645-1041-1

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 ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltd42778607-6170-4a5e-94d0-5e6cd064eec62023-10-22WarningsExact identifier
ndc (package): 34645-1041-1
ndc (product): 34645-1041
ndc11 (package): 34645104101
spl id: 085b28a4-8daa-0685-e063-6294a90a0d08
spl set id: 42778607-6170-4a5e-94d0-5e6cd064eec6

Reported adverse events (FAERS/openFDA)#

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