FDA.reportPublic FDA data

First Aid Only Povidone-Iodine Antiseptic

Manufacturer
Acme United Corporation
Effective date
2024-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:51:06

Label at a glance#

ProductFirst Aid Only Povidone-Iodine Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure9 sections

Dosage and administration

Open packet and wipe affected area. Apply 1 to 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-Iodine Solution 10%

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent skin infection.

Warnings:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use▪ in eyes ▪ over large areas of the body ▪ if allergic to any of the ingredients

▪ longer than 1 week unless directed by a doctor.

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have ▪ deep or puncture wounds ▪ animal bites ▪ serious burns.

OTC - STOP USE SECTION

Stop use and ask a doctor if ▪ conditions worsen or clear up and then recur

▪ the condition persists for more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Open packet and wipe affected area. Apply 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first..

Other Information:

OTHER SAFETY INFORMATION

Store at room temperature..

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide,

purified water, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label ImageCarton Label Image

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-81120924-8112-01, 0924-8112-00, 0924-8112-02, 0924-8112-03
65517-0034

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
NONOXYNOL-10K7O76887APIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POTASSIUM IODIDE1C4QK22F9JIACT
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
PVP-I Prep Pads foil-foilPOVIDONE-IODINEDukal LLC95c35c0d-bebb-46d0-8e97-f3d2541723ad2025-11-19WarningsExact identifier
ndc (product): 65517-0034
256a4e5f-bc97-cece-e063-6294a90a866a9b7f2fc2-f201-2746-e053-2a95a90ac0d82024-10-26WarningsExact identifier
spl id: 256a4e5f-bc97-cece-e063-6294a90a866a
spl set id: 9b7f2fc2-f201-2746-e053-2a95a90ac0d8

Reported adverse events (FAERS/openFDA)#

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