FDA.reportPublic FDA data

First Aid Only Povidone-Iodine Prep Pad

Manufacturer
Acme United Corporation
Effective date
2024-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:36:28

Label at a glance#

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

Dosage and administration

Directions Apply locally as needed.

Storage and handling

Other Information Store at room temperature 15° - 30°C (59° - 86°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Povidone Iodine 10%

Purpose

OTC - PURPOSE SECTION

Purpose Antiseptic

Use

INDICATIONS & USAGE SECTION

Use Antispetic for preparation of the skin.

Warnings

WARNINGS SECTION

Warnings •For external use only.

•Discontinue use if irritation and redness develop.

•Keep out of reach of children.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Apply locally as needed.

Other Information

STORAGE AND HANDLING SECTION

Other Information Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredient purified water

Package Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ImageLabel Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-8110-00First Aid Only Povidone-Iodine Prep Pad0.45 g in 1 PATCHPATCH0.452
0924-8110-00First Aid Only Povidone-Iodine Prep Pad1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-8110FIRST AID ONLY POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) PATCH [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241110_509b6c8e-6a9f-2656-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-81100924-8110-00
44019-811

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
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
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
ndc (package): 0924-8110-00
ndc (product): 0924-8110
ndc11 (package): 00924811000
spl id: 26800a2d-7585-2058-e063-6394a90ad720
spl set id: 509b6c8e-6a9f-2656-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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