FDA.reportPublic FDA data

Povidone-Iodine Prep

Manufacturer
Acme United Corporation
Effective date
2020-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:46:42

Label at a glance#

ProductPovidone-Iodine Prep
Active ingredientPOVIDONE-IODINE
Label structure7 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine 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

Do not use

OTC - DO NOT USE SECTION

• in eyes • over large areas of the body • if allergic to any of the ingredients • longer than 1 week unless directed by a doctor

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

• conditions worsen or clear up and then recur • the condition persists for more than 7 days

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

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 Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-81110924-8111-01
59050-060

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
NONOXYNOL-10K7O76887APIACT
POTASSIUM IODIDE1C4QK22F9JIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
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
9b910919-2255-7c9b-e053-2a95a90a0b0a6ba0600c-03d3-e39b-e053-2a91aa0a62342020-01-07WarningsExact identifier
spl id: 9b910919-2255-7c9b-e053-2a95a90a0b0a
spl set id: 6ba0600c-03d3-e39b-e053-2a91aa0a6234

Reported adverse events (FAERS/openFDA)#

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