0012 Aplicare Povidone-Iodine Solution (non-sterile)

Manufacturer: Aplicare Products, LLC | Medline Industries, LP
Effective date: 2024-12-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 20:45:55

Label at a glance#

ProductAplicare

Active ingredientPOVIDONE-IODINE

Label structure9 sections

Indications and uses

for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

Dosage and administration

antiseptic skin preparation: apply locally as needed.

Storage and handling

1% titratable iodine not made with natural rubber latex for hospital or professional use only protect from freezing, avoid excessive heat store at room temperature

Contacts and useful links#

Websitewww.medline.com

www.medline.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine USP 10% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

for preparation of the skin prior to surgery
helps reduce bacteria that potentially can cause skin infection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if allergic to iodine
in the eyes or apply over large areas of the body
in case of deep or puncture wounds, animals bites, or serious burns, consult a doctor

Discontinue use if

OTC - STOP USE SECTION

irritation and redness develop.
If condition persists for more than 72 hours consult a doctor

Avoid pooling beneath patient

OTHER SAFETY INFORMATION

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

antiseptic skin preparation: apply locally as needed.

Other information

STORAGE AND HANDLING SECTION

1% titratable iodine
not made with natural rubber latex
for hospital or professional use only
protect from freezing, avoid excessive heat
store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

Manufacturing information

SPL UNCLASSIFIED SECTION

Aplicare is a registered trademark of Medline Industries, LP

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE Made in China. V1 RL24CZU

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52380-0012	APLICARE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]	2	Unmatched	20241215_29049f69-1ffd-ca59-e063-6394a90a244f.zip

Products#

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

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

Aplicare
Povidone-Iodine
IODINE
C12-20 ALKYL GLUCOSIDE
SODIUM HYDROXIDE
NONOXYNOL-10
HYDROXYETHYL CELLULOSE, UNSPECIFIED
GLYCERIN
CITRIC ACID
POTASSIUM IODIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52380-0012	52380-0012-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POVIDONE-IODINE	85H0HZU99M	ACTIM
C12-20 ALKYL GLUCOSIDE	K67N5Z1RUA	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
NONOXYNOL-10	K7O76887AP	IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIED	T4V6TWG28D	IACT
GLYCERIN	PDC6A3C0OX	IACT
CITRIC ACID	2968PHW8QP	IACT
POTASSIUM IODIDE	1C4QK22F9J	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
44e780cc-13fe-dd55-e063-6294a90ad46a			29049f69-1ffd-ca59-e063-6394a90a244f	2025-12-01	Warnings	Exact identifier spl set id: 29049f69-1ffd-ca59-e063-6394a90a244f

Reported adverse events (FAERS/openFDA)#

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