FDA.reportPublic FDA data

Povidone-Iodine Solution, sterile

Manufacturer
Asia Dynamics Inc., d/b/a ADI Medical
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:06:52

Label at a glance#

Productsterile
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Dosage and administration

apply locally as needed

Storage and handling

Avoid excessive heat Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-lodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

for antiseptic skin preparation

Warnings

WARNINGS SECTION

For external use only

Avoid pooling beneath patient

do not use

OTC - DO NOT USE SECTION

  • if allergic to lodine
  • in the eye

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • serious burns

Directions

DOSAGE & ADMINISTRATION SECTION

apply locally as needed

Other information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • for hospital or professional use only

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Nonyl Nonoxynol-10, Glycerin, Purifed Water.

Storage

STORAGE AND HANDLING SECTION

Avoid excessive heat

Store at room temperature

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelNDC 83645-552-11

ADI Medical

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN1
312564povidone-iodine 100 MG/ML Topical SolutionSCD1
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY1

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
83645-551-11sterile22.5 g in 1 BOTTLESOLUTION22.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83645-551STERILE (POVIDONE-IODINE) SOLUTION [ASIA DYNAMICS INC., D/B/A ADI MEDICAL]11 package rows20240110_0e77e4fc-75e0-f4e1-e063-6294a90a49e9.zip

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
83645-55183645-551-11

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
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
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
0e77e515-b084-13af-e063-6394a90ad9dd0e77e4fc-75e0-f4e1-e063-6294a90a49e92024-01-05WarningsExact identifier
spl id: 0e77e515-b084-13af-e063-6394a90ad9dd
spl set id: 0e77e4fc-75e0-f4e1-e063-6294a90a49e9

Reported adverse events (FAERS/openFDA)#

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