FDA.reportPublic FDA data

Povidone Iodine Surgical Scrub

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2021-03-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:39:18

Label at a glance#

ProductPovidone Iodine Surgical Scrub
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Storage and handling

Other Information Store at room temperature Avoid excessive heat above 40 o C (104 o F) Protect from freezing Latex free

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Povidone Iodine 10%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use

For cleansing hands and arms prior to surgery

WARNINGS SECTION

Warnings

For external use only

Do not use in the eyes

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

DOSAGE & ADMINISTRATION SECTION

Directions

Wet hands and forearms with water

Clean under nails with nail cleaner

Scrub for 3 minutes with the impregnated brush

Pay close attention to the nails, cuticles, and interdigital spaces

Rinse thoroughly with running water

Repeat

STORAGE AND HANDLING SECTION

Other Information

Store at room temperature

Avoid excessive heat above 40 o C (104 oF)

Protect from freezing

Latex free

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Hydroxyethylcellulose, Nonoxynol - 10, Purified Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pouch LabelPouch Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34645-4021-72023-01-30C16284748780-1f386c649-e9fb-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-4021-7Povidone Iodine Surgical Scrub20 mL in 1 POUCHSPONGE206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4021POVIDONE IODINE SURGICAL SCRUB (POVIDONE IODINE) SPONGE [JIANERKANG MEDICAL CO., LTD]6Legacy NDC, 1 package rows20210330_9377d7e8-e7b5-40e1-ba91-decb476c0752.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 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-402134645-4021-7

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
NONOXYNOL-10K7O76887APIACT
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
beac24d4-f9f1-7f26-e053-2995a90a96f29377d7e8-e7b5-40e1-ba91-decb476c07522021-03-29WarningsExact identifier
spl id: beac24d4-f9f1-7f26-e053-2995a90a96f2
spl set id: 9377d7e8-e7b5-40e1-ba91-decb476c0752

Reported adverse events (FAERS/openFDA)#

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