FDA.reportPublic FDA data

Aplicare Povidone-Iodine

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:42:56

Label at a glance#

ProductAplicare Povidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure9 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
  • Avoid pooling beneath patient
  • Avoid excessive heat. Store at room temperature

Do not use

OTC - DO NOT USE SECTION

  • • if allergic to iodine
  • • in the eyes

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • • deep or puncture wounds
  • • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

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

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured by: Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE

Aplicare is a registered trademark of Medline Industries, LP.

REF: APLL30115S

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfront

back1back1

front3front3

back3back3

Rev V1 RI21APLRev V1 RI21APL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN13
312564povidone-iodine 100 MG/ML Topical SolutionSCD13
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY13

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
52380-0011-1Aplicare Povidone-Iodine30 mL in 1 PACKETSOLUTION3013
52380-0011-3Aplicare Povidone-Iodine22.5 mL in 1 PACKETSOLUTION22.513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0011-1ML - Milliliter52380-0011d51b0835-c89f-4fe4-8859-36c1b27d1a6712017-07-07
52380-0011-3ML - Milliliter52380-001108504a51-dc00-44b1-bfe2-207aa1beb2f612023-09-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-001152380-0011-1, 52380-0011-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122023-10-18full-release2026-05-31 23:56:57

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
4304af18-bbbb-1fae-e063-6294a90a8130b760668f-31be-47fa-9eee-38cb67780e212025-11-07WarningsExact identifier
spl id: 4304af18-bbbb-1fae-e063-6294a90a8130
spl set id: b760668f-31be-47fa-9eee-38cb67780e21

Reported adverse events (FAERS/openFDA)#

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