FDA.reportPublic FDA data

Povidone Iodine

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:16

Label at a glance#

ProductPovidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Uses

Prepping intact skin and mucous membranes prior to surgery

WARNINGS SECTION

Warnings

For external use only

Avoid use on persons allergic to iodine

OTC - STOP USE SECTION

Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

INDICATIONS & USAGE SECTION

Directions

Patient preoperative prep

use full strength

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 not allow solution to pool


Other information

DOSAGE & ADMINISTRATION SECTION

store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free


INACTIVE INGREDIENT SECTION

Inactive Ingredients

Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pouch LabelPouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN6
312564povidone-iodine 100 MG/ML Topical SolutionSCD6
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY6

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
34645-4188-6Povidone Iodine88.5 mL in 1 BOTTLE, PLASTICSOLUTION88.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4188POVIDONE IODINE SOLUTION [JIANERKANG MEDICAL CO., LTD]6Current NDC, Legacy NDC, 1 package rows20231023_0bd3de76-b726-41f1-87bc-14ab8a1eca8e.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
34645-418834645-4188-6

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 IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
ndc (package): 34645-4188-6
ndc (product): 34645-4188
ndc11 (package): 34645418806
spl id: 085bc532-b22e-8f18-e063-6394a90a03ae
spl set id: 0bd3de76-b726-41f1-87bc-14ab8a1eca8e

Reported adverse events (FAERS/openFDA)#

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