FDA.reportPublic FDA data

POVIDONE IODINE TOPICAL SOLUTION USP

Manufacturer
James Alexander Corporation
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:39:48

Label at a glance#

ProductPOVIDONE-IODINE
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Indications and uses

To treat minor skin cuts and abrasions.

Dosage and administration

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Label contents#

Full prescribing information#

Active Ingredients (each swab)

OTC - ACTIVE INGREDIENT SECTION

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

To treat minor skin cuts and abrasions.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have • deep or puncture wounds • serious burns

Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases
                                                • infection occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Other Information

OTHER SAFETY INFORMATION

 Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.

SPL UNCLASSIFIED SECTION

DISPENSING SOLUTIONS®

JAMES ALEXANDER CORPORATION
Blairstown, NJ• (908) 362-9266
Product information and MSDS available on-line at:
www.james-alexander.com

Void of Aqueous

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN9
312564povidone-iodine 100 MG/ML Topical SolutionSCD9
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130033007330078GTIN-13: 0033007330078
EAN-13: 0033007330078
GTIN-12: 033007330078
UPC-A: 033007330078
GTIN storage (14 digits): 00033007330078		label-1.jpg

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
46414-7777-2POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.69
46414-7777-2POVIDONE-IODINE100 in 1 CONTAINERSOLUTION1009
46414-7777-3POVIDONE-IODINE10 in 1 CONTAINERSOLUTION109
46414-7777-3POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
IODINEACTIVE MOIETY9679TC07X42
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP2
nonoxynol-9INACTIVE INGREDIENT48Q180SH9T2
phosphate ionINACTIVE INGREDIENTNK08V8K8HR2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
waterINACTIVE INGREDIENT059QF0KO0R2

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
46414-777746414-7777-3, 46414-7777-2

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-12-13full-release2026-06-01 00:43:43

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
nonoxynol-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
nonoxynol-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
nonoxynol-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
nonoxynol-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
nonoxynol-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
nonoxynol-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 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-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
ndc (package): 46414-7777-3
ndc (package): 46414-7777-2
ndc (product): 46414-7777
ndc11 (package): 46414777703
ndc11 (package): 46414777702
spl id: a0c3cfbd-f346-4c1b-be91-c04b077c4bd3
spl set id: 181a6363-2249-45f0-a28b-79f2c5ffad59

Reported adverse events (FAERS/openFDA)#

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