FDA.reportPublic FDA data

Leader Decolorized Iodine

Manufacturer
Cardinal Health, 110 dba Leader
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:24

Label at a glance#

ProductLeader Decolorized Iodine
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 48%

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.

WARNINGS SECTION

For External Use Only.

When using this product:

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Soap will deactivate the effects of this product.

INACTIVE INGREDIENT SECTION

  • Ammonium Hydroxide
  • Iodine
  • Potassium Iodide
  • Purified Water

OTC - PURPOSE SECTION

First Aid Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ssss

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1804178ethanol 48 % Topical SolutionPSN5
1804178ethanol 0.48 ML/ML Topical SolutionSCD5
1804178ethanol 48 % Topical SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0399-12024-05-13C16284748780-11030e365-527f-111a-e063-dadaa90a10e2LEADER Decolorized Iodine
70000-0399-12024-01-30C16284748780-11030e365-527f-111a-e063-dadaa90a10e2LEADER Decolorized Iodine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0399-1Leader Decolorized Iodine59 mL in 1 CONTAINERLIQUID595

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0399LEADER DECOLORIZED IODINE (ALCOHOL LIQUID) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20240514_822f6f28-956f-dd82-e053-2991aa0ae752.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0399-1ML - Milliliter70000-0399da8aa99b-8f2f-4047-9a81-a3163e74af8112019-11-12

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-039970000-0399-1

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
NameUNIIKind
POTASSIUM IODIDE1C4QK22F9JIACT
AMMONIA5138Q19F1XIACT
WATER059QF0KO0RIACT
IODINE9679TC07X4IACT
ALCOHOL3K9958V90MACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
ndc (package): 70000-0399-1
ndc (product): 70000-0399
ndc11 (package): 70000039901
spl id: 1855c514-c6e0-9faa-e063-6394a90aee66
spl set id: 822f6f28-956f-dd82-e053-2991aa0ae752

Reported adverse events (FAERS/openFDA)#

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