FDA.reportPublic FDA data

Aplicare Povidone-iodine Scrub Sponge Sticks

Manufacturer
Aplicare, Inc.
Effective date
2017-05-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:50:00

Label at a glance#

ProductAplicare Povidone-iodine Scrub Sponge Sticks
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

use sponges to prep desired area

Storage and handling

1% titratable iodine for single use only not made with natural rubber latex for hospital or professional use only

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

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 wounds
  • 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

SPL UNCLASSIFIED SECTION

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

SPL UNCLASSIFIED SECTION

Avoid excessive heat. Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

use sponges to prep desired area

Other information

STORAGE AND HANDLING SECTION

  • 1% titratable iodine
  • for single use only
  • 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

OTC - QUESTIONS SECTION

For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST

PRINCIPAL DISPLAY PANEL - 2 Sponge Stick Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52380-4124-2

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▸

TWO POVIDONE-IODINE SCRUB
SPONGE STICKS

ANTISEPTIC
Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with
Povidone-Iodine Scrub USP

PRINCIPAL DISPLAY PANEL - 2 Sponge Stick Packet
PRINCIPAL DISPLAY PANEL - 2 Sponge Stick Packet

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-4124-22020-01-31C16284748780-19d75b9d0-ae8b-f424-e053-dadaa90a57ceAplicare Povidone-iodine Scrub Sponge Sticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-4124-2Aplicare Povidone-iodine Scrub Sponge Sticks90 mL in 1 PACKETSOLUTION901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-4124APLICARE POVIDONE-IODINE SCRUB SPONGE STICKS (POVIDONE-IODINE SCRUB) SOLUTION [APLICARE, INC.]1Legacy NDC, 1 package rows20170601_0b17ae69-0f5d-4425-a4c6-49791630d3c0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-4124-2EA - Each52380-41247bc1b8fe-9b19-4810-a586-7a222117b4f512017-07-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-412452380-4124-2

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
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
AMMONIUM NONOXYNOL-4 SULFATE9HIA70O4J0IACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5a660f4f-841a-4c66-8218-952ac05156210b17ae69-0f5d-4425-a4c6-49791630d3c02017-05-31WarningsExact identifier
spl id: 5a660f4f-841a-4c66-8218-952ac0515621
spl set id: 0b17ae69-0f5d-4425-a4c6-49791630d3c0

Reported adverse events (FAERS/openFDA)#

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