Aplicare Povidone-Iodine

Manufacturer: Aplicare Products, LLC | Medline Industries, LP
Effective date: 2022-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 21
Source: legacy-cache
Hydrated at: 2026-08-01 21:44:17

Label at a glance#

ProductAplicare Povidone-Iodine

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
Avoid excessive heat. Stre at room temperature

Do not use

OTC - DO NOT USE SECTION

• if allergic to iodine
• in the eyes

Ask 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 cas of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply locally as needed

Other information

OTHER SAFETY INFORMATION

• 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 Parkway, Meriden,

CT 06450 USA

Made in USA

1-800-633-5463

0917

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rev 0917 Front

Rev 0917 Back

Rev V1 RI21APL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52380-0001	APLICARE POVIDONE-IODINE (POVIDONE-IODINE) SOLUTION [APLICARE PRODUCTS, LLC]	21	Legacy NDC	20221217_6fd83afc-e12f-41d5-a9b4-ad233bd352f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52380-0001-1	ML - Milliliter	52380-0001	edd25a2a-aabd-433e-b5a8-ef9471c1b244	1	2012-07-24
52380-0001-3	ML - Milliliter	52380-0001	9f05eb45-3f8e-4fd9-814a-476eb917bf5c	1	2021-11-09
52380-0001-5	EA - Each	52380-0001	9755da7f-19a8-4706-8c70-17752ffe4175	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	8
IODINE	ACTIVE MOIETY	9679TC07X4	8
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	8
NONOXYNOL-9	INACTIVE INGREDIENT	48Q180SH9T	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	8
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	8

Products#

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

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

Aplicare Povidone-Iodine
POVIDONE-IODINE
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
NONOXYNOL-9
SODIUM HYDROXIDE
WATER
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52380-0001	52380-0001-1, 52380-0001-3, 52380-0001-5

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 278 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	78.36 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	0.35 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAMUSCULAR		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET / ORAL		10 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTERIAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates

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
4302f2a3-0ca4-03b1-e063-6294a90a70a4			6fd83afc-e12f-41d5-a9b4-ad233bd352f2	2025-11-07	Warnings	Exact identifier spl set id: 6fd83afc-e12f-41d5-a9b4-ad233bd352f2

Reported adverse events (FAERS/openFDA)#

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