FDA.reportPublic FDA data

Povidone Iodine Prep

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 23:57:18

Label at a glance#

ProductPovidone Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure7 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. For use as a first aid antiseptic  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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

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

OTC - DO NOT USE SECTION

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

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 a Poison Control Center right away.

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. For use as a first aid antiseptic 
  • 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

SPL UNCLASSIFIED SECTION

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

  • Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
34645-5503-0Povidone Iodine Prep10 in 1 CARTONSOLUTION104
34645-5503-0Povidone Iodine Prep50 in 1 BOXSOLUTION504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5503POVIDONE IODINE PREP (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_47a5690c-08bf-5092-e054-00144ff8d46c.zip

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
34645-550334645-5503-0

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
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
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 Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
ndc (package): 34645-5503-0
ndc (product): 34645-5503
ndc11 (package): 34645550300
spl id: 085c95d0-d8b1-1513-e063-6294a90a8312
spl set id: 47a5690c-08bf-5092-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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