FDA.reportPublic FDA data

2801Aplicare Povidone Iodine Solution

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:26:44

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 10%
(equivalent to 1% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

OTC - DO NOT USE SECTION

  • • in the eyes
  • • on individuals allergic or sensitive to iodine

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

  • • infection occurs
  • • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply locally as needed

Other information

OTHER SAFETY INFORMATION

  • • 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:

Aplicare Products, LLC

550 Research Way, Meriden, CT 06450 USA

Made in USA

REF: APL82342K

RL17HND

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312564povidone-iodine 10 % Topical SolutionPSN8
312564povidone-iodine 100 MG/ML Topical SolutionSCD8
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00352380280184GTIN-14: 00352380280184
GTIN-12: 352380280184
UPC-A: 352380280184
EAN-13: 0352380280184
GTIN storage (14 digits): 00352380280184		52380-2801.jpg

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
52380-2801-8Aplicare Povidone-Iodine59 mL in 1 BOTTLESOLUTION598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M2
IODINEACTIVE MOIETY9679TC07X42
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA742
WATERINACTIVE INGREDIENT059QF0KO0R2

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
52380-280152380-2801-8

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
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii+dosage form
4 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii+dosage form
4 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii+route
4 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii+route
4 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates

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
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC1ad9237e-80ee-4769-ba53-9bc1bb6672492025-12-18WarningsExact identifier
ndc (package): 52380-2801-8
ndc (product): 52380-2801
ndc11 (package): 52380280108
spl id: 4640c80b-048c-1a17-e063-6394a90a1dbb
spl set id: 1ad9237e-80ee-4769-ba53-9bc1bb667249

Reported adverse events (FAERS/openFDA)#

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