FDA.reportPublic FDA data

Aplicare Povidone Iodine Swabstick

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2021-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:25:07

Label at a glance#

ProductAplicare Povidone Iodine Swabstick
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

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.

Storage Information

STORAGE AND HANDLING SECTION

Avoid excessive heat. Store at room temperature.

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:

Aplicare Products, LLC

550 Research Pkwy, Meriden, CT 06450 USA

Made in USA

1-800-633-5463

REF: APLS1111

0117

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1 Swabstick PacketPRINCIPAL DISPLAY PANEL - 1 Swabstick Packet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-4101-1EA - Each52380-41018c515672-b6b9-4e52-80d4-20be7f9f236a12017-07-07

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-410152380-4101-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
AMMONIUM NONOXYNOL-4 SULFATE9HIA70O4J0IACT
SODIUM HYDROXIDE55X04QC32IIACT
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
d22cbf80-f3ff-6447-e053-2995a90a035cd1d9daeb-039e-4f28-8eec-6403c8ffb7522021-12-02WarningsExact identifier
spl id: d22cbf80-f3ff-6447-e053-2995a90a035c
spl set id: d1d9daeb-039e-4f28-8eec-6403c8ffb752

Reported adverse events (FAERS/openFDA)#

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