FDA.reportPublic FDA data

POVIDONE IODINE TOPICAL SOLUTION USP

Manufacturer
Acme United Corporation | Acmne United Corporation
Effective date
2025-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:05:59

Label at a glance#

ProductPOVIDONE-IODINE
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

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

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

Warnings

WARNINGS SECTION

For external use only.

Do not use in the eyes; if you are allergic to any of the ingredients; longer than 1 week unless directed by a doctor.

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 1-800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton label carton labelcarton label

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
0924-5408-00POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.61
0924-5408-01POVIDONE-IODINE10 in 1 CONTAINERSOLUTION101
0924-5408-02POVIDONE-IODINE100 in 1 CONTAINERSOLUTION1001

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
0924-54080924-5408-00, 0924-5408-01, 0924-5408-02
46414-7777

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
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
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 · 2 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 (product): 46414-7777
POVIDONE-IODINEPOVIDONE-IODINEAcme United Corporation37c709ae-ef37-0b46-e063-6394a90af8612025-06-17WarningsExact identifier
ndc (package): 0924-5408-02
ndc (package): 0924-5408-00
ndc (package): 0924-5408-01
ndc (product): 0924-5408
ndc11 (package): 00924540802
ndc11 (package): 00924540800
ndc11 (package): 00924540801
spl id: 37c711e4-c7ae-0b71-e063-6394a90ad93e
spl set id: 37c709ae-ef37-0b46-e063-6394a90af861

Reported adverse events (FAERS/openFDA)#

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