FDA.reportPublic FDA data

Aplicare Povidone-Iodine Prep Pad

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2023-01-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:41:29

Label at a glance#

ProductAplicare Povidone-Iodine Prep Pad
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 or in the eyes

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • if injuries are deep wounds, puncture wounds, or serious burns

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if infection occurs or if 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 locally as needed

Other Information

SPL UNCLASSIFIED SECTION

  • Prep pad size: 1-1/4" × 1-1/2"
  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • avoid excessive heat - store at room temperature

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

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

RF18APL

REF: APLP1111

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-4111-1EA - Each52380-41111ce3a248-cd55-4898-a208-867281187cd412017-07-07

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-411152380-4111-1, 52380-4111-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
NONOXYNOL-948Q180SH9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
026e6470-d4e1-e0ef-e063-6294a90add143d9b1d83-e5d1-4982-81ab-a7ebedaccc392023-08-08WarningsExact identifier
spl set id: 3d9b1d83-e5d1-4982-81ab-a7ebedaccc39

Reported adverse events (FAERS/openFDA)#

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