FDA.reportPublic FDA data

5972 Aplicare Povidone Iodine Gel Swabstick

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:24:42

Label at a glance#

ProductAplicare Povidone Iodine Swabstick
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

• apply locally as needed

Storage and handling

Avoid excessive heat. Store at room temperature.

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

disodium phosphate, glycerin, hydroxy ethylcellulose, nonoxynol-10, simethicone, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured by:
Aplicare Products, LLC
550 Research Parkway, Meriden, CT 06450 USA
Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in USA with domestic and foreign materials
1-800-633-5463
REF: APLS1148
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
52380-5972-1EA - Each52380-59723894da9c-5c86-4636-87ae-fa4df63041c612017-09-11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-597252380-5972-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16IACT
NONOXYNOL-10K7O76887APIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML · Source PDF

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
d27eb86f-ab12-f889-e053-2a95a90ad7dfb935bf68-6b54-46d2-aed3-b3b9ba6aabfb2021-12-06WarningsExact identifier
spl id: d27eb86f-ab12-f889-e053-2a95a90ad7df
spl set id: b935bf68-6b54-46d2-aed3-b3b9ba6aabfb

Reported adverse events (FAERS/openFDA)#

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