Decolorized Iodine

Manufacturer: Cardinal Health | Humco Holding Group, Inc.
Effective date: 2020-03-20
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:38:24

Label at a glance#

ProductDecolorized Iodine

Active ingredientALCOHOL

Label structure9 sections

Dosage and administration

Clean the affected area. apply a small amount on the area 1 to 3 times daily. may be covered with sterile bandage. if bandaged, let dry first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 48%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame

SPL UNCLASSIFIED SECTION

When using this product

OTC - WHEN USING SECTION

do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult doctor if the

OTC - STOP USE SECTION

condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area.
apply a small amount on the area 1 to 3 times daily.
may be covered with sterile bandage.
if bandaged, let dry first.

Other information

OTHER SAFETY INFORMATION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, iodine, potassium iodide, and purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-648-16
Leader ^®
Decolorized Iodine
Alcohol 48%
FIRST AID ANTISEPTIC
For External Use Only
2 FL OZ (59 mL)

NDC 37205-648-16 Leader® Decolorized Iodine Alcohol 48% FIRST AID ANTISEPTIC For External Use Only 2 FL OZ (59 mL)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-648-16	ML - Milliliter	37205-648	e1c04512-3ec7-464e-8bed-04caf9ffaaef	1	2013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	3
ALCOHOL	ACTIVE MOIETY	3K9958V90M	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	3
IODINE	INACTIVE INGREDIENT	9679TC07X4	3
POTASSIUM IODIDE	INACTIVE INGREDIENT	1C4QK22F9J	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Decolorized Iodine
Ethyl Alcohol
AMMONIA
IODINE
POTASSIUM IODIDE
WATER
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-648	37205-648-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMMONIA	5138Q19F1X	IACT
IODINE	9679TC07X4	IACT
POTASSIUM IODIDE	1C4QK22F9J	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	ACTIB

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 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SOLUTION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	FILM / SUBLINGUAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE / ORAL	0.01 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	LOTION / TOPICAL	ADJ PH		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	GEL / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	INJECTION / INTRAVENOUS	0.22 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CREAM / TOPICAL	5.72 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
AMMONIA	AMMONIA SOLUTION	5138Q19F1X	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 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
e42a2cb8-3fb3-6844-e053-2995a90a59b0			586df152-8661-4540-ada6-20148d77b310	2022-07-19	Warnings	Exact identifier spl set id: 586df152-8661-4540-ada6-20148d77b310

Reported adverse events (FAERS/openFDA)#

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