FDA.reportPublic FDA data

4802 Povidone-iodine Scrub NonSterile

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2026-09-02
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-09-08 02:01:21

Label at a glance#

ProductAplicare Povidone-iodine Scrub
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Dosage and administration

apply topically as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 7.5%

(equivalent to 0.75% 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 topically as needed

Other information

OTHER SAFETY INFORMATION

  • Not made with natural rubber latex
  • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions or comments?

OTC - QUESTIONS SECTION

www. medline.com 1-800-Medline

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured in USA by Medline

Inustries, LP, Three Lakes Drive,

Northfield, IL 60093 USA

www.medline.com 1-800-Medline

REF: APL82364K

RECENT MAJOR CHANGES SECTION

Updated dosage and administration section on September 2, 2026

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EachEach

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00352380480287GTIN-14: 00352380480287
GTIN-12: 352380480287
UPC-A: 352380480287
EAN-13: 0352380480287
GTIN storage (14 digits): 00352380480287		52380-4802-8 V1 RG24HND.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-4802-82021-01-07C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82021-01-07C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-09-27C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-09-27C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-09-25C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-09-25C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-07-22C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile
52380-4802-82020-07-22C16284748780-1ab0e2407-3500-f274-e053-dbdaa90a64714802 Povidone-iodine Scrub NonSterile

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M6
IODINEACTIVE MOIETY9679TC07X46
AMMONIUM NONOXYNOL-4 SULFATEINACTIVE INGREDIENT9HIA70O4J06
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL6
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I6
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA746
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-480252380-4802-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
AMMONIUM NONOXYNOL-4 SULFATE9HIA70O4J0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142025-12-18full-release2026-06-01 01:26:56

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
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-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii+route
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 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
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SOLUTION / ORAL40 mg/1mlExact identifier — unii+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact 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
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact 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-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsExact identifier
ndc (package): 52380-4802-8
ndc (product): 52380-4802
ndc11 (package): 52380480208
spl id: 5a8748b6-17b0-cdca-e063-6394a90ad140
spl set id: b8a23a29-2541-4987-a534-17a6369a6c8d

Reported adverse events (FAERS/openFDA)#

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