FDA.reportPublic FDA data

Povidone Iodine Scrub

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:26

Label at a glance#

ProductPovidone Iodine Scrub
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

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.

Dosage and administration

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

Storage and handling

store at room temperature: 15°－30°C(59°-86°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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.

Warnings

WARNINGS SECTION

For external use only.

  • Do not use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body use as a first aid antiseptic longer than 1 week unless directed by a doctor.
  • if irritation and redness develop. Consult a doctor in case of deep or puncture wounds animal bites serious burns. Discontinue use

Stop use and consult a doctor

OTC - STOP USE SECTION

if the condition persists or gets worse.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For preparation of the skin prior to surgery

For use as a first aid antiseptic

  • clean the affected area
  • remove swab by stick
  • apply to the operative site prior to surgery. F
  • clean the affected area
  • apply a small amount of this product on the area 1-3 times daily
  • may be covered with a sterile bandage
  • if bandaged,let dry first.

Other information

STORAGE AND HANDLING SECTION

store at room temperature: 15°－30°C(59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, distilled water, sodium hydroxide, alkyl polyglucoside nonylphenol ethoxylate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

l1l1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037204povidone-iodine 7.5 % Medicated PadPSN4
1037204povidone-iodine 75 MG/ML Medicated PadSCD4
1037204povidone-iodine 7.5 % (titratable iodine 0.75 % ) Topical SwabSY4
1037204povidone-iodine 7.5 % Medicated PadSY4

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
34645-1044-1Povidone Iodine Scrub45 mL in 1 APPLICATORSWAB454
34645-1044-1Povidone Iodine Scrub3 in 1 POUCHSWAB34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-1044POVIDONE IODINE SCRUB (POVIDONE IODINE) SWAB [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231024_7ece9211-e9ee-43bc-b006-469ea3f4c09e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AU1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34645-104434645-1044-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %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 ScrubPOVIDONE IODINEJianerkang Medical Co., Ltd7ece9211-e9ee-43bc-b006-469ea3f4c09e2023-10-23WarningsExact identifier
ndc (package): 34645-1044-1
ndc (product): 34645-1044
ndc11 (package): 34645104401
spl id: 085eb630-8dae-1fca-e063-6294a90af6cc
spl set id: 7ece9211-e9ee-43bc-b006-469ea3f4c09e

Reported adverse events (FAERS/openFDA)#

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