Povidone Iodine Scrub

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 23:57:19

Label at a glance#

ProductPovidone Iodine Scrub
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Dosage and administration

For preparation of the skin prior to surgery clean the affected area, remove swab by stick apply to the operative site prior to surgery clean the affected area apply a small amount of this products on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first For use as a first aid antiseptic

Storage and handling

store at room temperature: 15o - 30oC (59o-86oF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine USP, 7.5% W/V (equivalent to 0.75% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Health-care antiseptic for preparation of the skin prior to surgery First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns Use

WARNINGS SECTION



Warnings For external use only

OTC - DO NOT USE SECTION

use in the eyes use on individuals who are allergic or sensitive to iodine apply over larger areas of the body use as a first aid antiseptic longer than 1 week unless by a doctor Do not



OTC - DO NOT USE SECTION

if irritation and redness develop, consult a doctor in case of deep or puncture wounds animal bites serious burns Discontinue use



OTC - DO NOT USE SECTION

Stop use and consult a doctor

if the condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

For preparation of the skin prior to surgery

clean the affected area, remove swab by stick apply to the operative site prior to surgery

clean the affected area apply a small amount of this products on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first For use as a first aid antiseptic



Other information

STORAGE AND HANDLING SECTION

store at room temperature: 15o - 30oC (59o-86oF)

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

INACTIVE INGREDIENT SECTION

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Pouch Label

Pouch LabelPouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037204povidone-iodine 7.5 % Medicated PadPSN6
1037204povidone-iodine 75 MG/ML Medicated PadSCD6
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY6
1037204povidone-iodine 7.5 % Medicated PadSY6

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
34645-4025-32021-03-29C16284748780-1ba0f9c33-49a7-a910-e053-dadaa90a0b85Drug Facts
34645-4025-32021-01-29C16284748780-1ba0f9c33-49a7-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-4025-3Povidone Iodine Scrub2.5 mL in 1 POUCHSWAB2.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-4025POVIDONE IODINE SCRUB (POVIDONE-IODINE) SWAB [JIANERKANG MEDICAL CO., LTD]6Current NDC, Legacy NDC, 1 package rows20231023_78131b57-1ffc-4eb8-821e-f7bb73300fe9.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
34645-402534645-4025-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
ndc (package): 34645-4025-3
ndc (product): 34645-4025
ndc11 (package): 34645402503
spl id: 085bb064-09fb-cb0d-e063-6294a90a16a1
spl set id: 78131b57-1ffc-4eb8-821e-f7bb73300fe9

Reported adverse events (FAERS/openFDA)#

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