FDA.reportPublic FDA data

POVIDONE IODINE TOPICAL SOLUTION USP

Manufacturer
HART Health
Effective date
2024-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:44

Label at a glance#

ProductPOVIDONE-IODINE
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

First aid topical antiseptic to help prevent infection in minor cuts scrapes abrasions

Dosage and administration

Adults and children 12 years of age and older: r everse cardboard sleeve crush at dot between thumb and forefinger to release fluid gently wipes injured area to clean and disinfect dispose of swab peoperly do not reuse swab Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 10% (available iodine 1%)

Purpose

OTC - PURPOSE SECTION

Topical antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid topical antiseptic to help prevent infection in

  • minor cuts
  • scrapes
  • abrasions

Warnings

WARNINGS SECTION

For external use only.

  • do not get in eyes

OTC - ASK DOCTOR SECTION

Ask a dcotor before use if you have

  • deep or puncture wounds
  • serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - DO NOT USE SECTION

Do not use

  • on animal bits
  • in or near the eyes or over large portions of the body

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

  • reverse cardboard sleeve
  • crush at dot between thumb and forefinger to release fluid
  • gently wipes injured area to clean and disinfect
  • dispose of swab peoperly
  • do not reuse swab

Children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

 Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVPswabv24f.jpgPVPswabv24f.jpgPVPswabv24f.jpgPVPswabv24f.jpg

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0056-1POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.61
50332-0056-1POVIDONE-IODINE10 in 1 BOX, UNIT-DOSESOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0056POVIDONE-IODINE SOLUTION [HART HEALTH]1Current NDC, 2 package rows20240217_92b6a38e-c7bb-45e2-9c2a-7993ed1bac36.zip

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
50332-005650332-0056-1

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
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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-IODINEPOVIDONE-IODINEHART Health92b6a38e-c7bb-45e2-9c2a-7993ed1bac362024-02-15WarningsExact identifier
ndc (package): 50332-0056-1
ndc (product): 50332-0056
ndc11 (package): 50332005601
spl id: 24fa6310-b8aa-47ed-bee9-419551419e8c
spl set id: 92b6a38e-c7bb-45e2-9c2a-7993ed1bac36

Reported adverse events (FAERS/openFDA)#

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