FDA.reportPublic FDA data

Aplicare Povidone-iodine Scrub Small Wing Sponge

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 Small Wing Sponge
Active ingredientPOVIDONE-IODINE
Label structure11 sections

Dosage and administration

use sponges to prep desired area

Storage and handling

Avoid excessive heat. Store at room temperature.

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

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.

STORAGE AND HANDLING SECTION

Avoid excessive heat. Store at room temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

use sponges to prep desired area

Other information

SPL UNCLASSIFIED 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 - 4 Sponge Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52380-5124-4

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

FOUR POVIDONE-IODINE SCRUB
SMALL WINGED SPONGES

ANTISEPTIC
Non-Sterile Solution

Four Small Winged Sponges Saturated with
Povidone-Iodine Scrub USP

Reorder No. F-4012

PRINCIPAL DISPLAY PANEL - 4 Sponge Packet
PRINCIPAL DISPLAY PANEL - 4 Sponge 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-5124-42020-01-31C16284748780-19d75b9d0-2926-f424-e053-dadaa90a57ceAplicare Povidone-iodine Scrub Small Wing Sponge

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52380-5124-4Aplicare Povidone-iodine Scrub Small Wing Sponge120 mL in 1 PACKETSOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52380-5124APLICARE POVIDONE-IODINE SCRUB SMALL WING SPONGE (POVIDONE-IODINE SCRUB) SOLUTION [APLICARE, INC.]1Legacy NDC, 1 package rows20170601_4f8a29aa-8f0f-4c62-8552-54b8bba9a613.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-5124-4EA - Each52380-5124621e2460-8636-47ea-a121-609fa1eae76e12017-07-07

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
52380-512452380-5124-4

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, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM HYDROXIDE55X04QC32IIACT
NONOXYNOL-948Q180SH9TIACT
AMMONIUM NONOXYNOL-4 SULFATE9HIA70O4J0IACT
WATER059QF0KO0RIACT

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
c1baa608-27fa-4efe-b0a4-b4c1c6c7489e4f8a29aa-8f0f-4c62-8552-54b8bba9a6132017-05-31WarningsExact identifier
spl id: c1baa608-27fa-4efe-b0a4-b4c1c6c7489e
spl set id: 4f8a29aa-8f0f-4c62-8552-54b8bba9a613

Reported adverse events (FAERS/openFDA)#

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