FDA.reportPublic FDA data

0126 Povidone-Iodine Ointment

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:38:52

Label at a glance#

ProductAplicare Povidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure8 sections

Dosage and administration

Apply locally as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine USP 10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

antiseptic skin preparation

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • if allergic to iodine or in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • deep wounds, puncture wounds, or serious burns

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if infection occurs or if redness, irritation, swelling or pain persists or increases.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

STORAGE AND HANDLING SECTION

  • Avoid excessive heat. Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply locally as needed.

Other Information

SPL UNCLASSIFIED SECTION

  • 1% titratable iodine
  • Not made with natural rubber latex
  • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, polyethylene glycol, propylene glycol

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1 gram Ointment PacketPRINCIPAL DISPLAY PANEL - 1 gram Ointment Packet

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0126-2GM - Gram52380-012691378eff-90d7-4a0b-b303-06dfab0c036912017-09-11

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-012652380-0126-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52023-02-16full-release2026-05-31 23:54:07

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
4308a97e-2692-211c-e063-6294a90a033cc6190453-4385-4be5-b4b9-4637b4e848452025-11-07WarningsExact identifier
spl id: 4308a97e-2692-211c-e063-6294a90a033c
spl set id: c6190453-4385-4be5-b4b9-4637b4e84845

Reported adverse events (FAERS/openFDA)#

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