First Aid Only Povidone-Iodine Antiseptic

Manufacturer
Acme United Corporation
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:17:13

Label at a glance#

ProductFirst Aid Only Povidone-Iodine Antiseptic
Active ingredientPOVIDONE-IODINE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-lodine 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 a 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 reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Driections

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 LABEL.PRINCIPAL DISPLAY PANEL

Pouch label Pouch LabelPouch Label

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
0924-8113-00First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-01First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-01First Aid Only Povidone-Iodine Antiseptic10 in 1 CARTONPATCH102
0924-8113-02First Aid Only Povidone-Iodine Antiseptic50 in 1 CARTONPATCH502
0924-8113-02First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-03First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-03First Aid Only Povidone-Iodine Antiseptic100 in 1 CARTONPATCH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-8113FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC (POVIDONE-IODINE) PATCH [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 7 package rows20240815_e0052ac2-4f74-32a4-e053-2995a90a94c6.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-81130924-8113-00, 0924-8113-01, 0924-8113-02, 0924-8113-03
59050-455

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
ndc (package): 0924-8113-00
ndc (package): 0924-8113-02
ndc (package): 0924-8113-01
ndc (package): 0924-8113-03
ndc (product): 0924-8113
ndc11 (package): 00924811303
ndc11 (package): 00924811300
ndc11 (package): 00924811301
ndc11 (package): 00924811302
spl id: 1f93db77-6db7-9866-e063-6394a90aa068
spl set id: e0052ac2-4f74-32a4-e053-2995a90a94c6
Prep non sterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdecbe037b-77da-4ffc-8c60-e56f428766af2023-11-15WarningsExact identifier
ndc (product): 59050-455

Reported adverse events (FAERS/openFDA)#

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