Aplicare Povidone-iodine Triples

Manufacturer: Aplicare Products, LLC | Medline Industries, LP
Effective date: 2025-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: monthly-update
Hydrated at: 2026-06-03 17:38:52

Label at a glance#

ProductAplicare Povidone-iodine Triples

Active ingredientPOVIDONE-IODINE

Label structure9 sections

Dosage and administration

apply locally as needed

Contacts and useful links#

PhoneLabel contact1-800-633-5463

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
Avoid pooling beneath patient

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
• for single 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 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: APLS3111

0117

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52380-5101-3	EA - Each	52380-5101	3ebcfd2d-985a-47db-ba3e-ec3167c76776	1	2017-07-07

Products#

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

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

Aplicare Povidone-iodine Triples
Povidone-iodine
SODIUM PHOSPHATE, DIBASIC
CITRIC ACID MONOHYDRATE
SODIUM HYDROXIDE
NONOXYNOL-9
WATER
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52380-5101	52380-5101-3, 52380-5101-2, 52380-5101-1, 52380-5101-5

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
Name	UNII	Kind
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
NONOXYNOL-9	48Q180SH9T	IACT
WATER	059QF0KO0R	IACT
POVIDONE-IODINE	85H0HZU99M	ACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2023-08-02	full-release	2026-05-31 23:55:48

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
4342550a-21fd-44e3-e063-6394a90aebfe			c674b28c-2c8d-43a8-9d6c-ab710e404089	2025-11-10	Warnings	Exact identifier spl id: 4342550a-21fd-44e3-e063-6394a90aebfe spl set id: c674b28c-2c8d-43a8-9d6c-ab710e404089

Reported adverse events (FAERS/openFDA)#

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