FDA.reportPublic FDA data

LEADER 2% Mild Iodine Tincture

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 2% Mild Iodine Tincture
Active ingredientSODIUM IODIDE, IODINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Iodine 2%

Sodium Iodide 2.4%

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

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.

DOSAGE & ADMINISTRATION SECTION

Clearn the affected area

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

OTC - PURPOSE SECTION

First Aid Antiseptic

INACTIVE INGREDIENT SECTION

Alcohol 47%

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mildiodinemildiodine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2284244iodine 2 % / sodium iodide 2.4 % Topical SolutionPSN5
2284244iodine 20 MG/ML / sodium iodide 24 MG/ML Topical SolutionSCD5
2284244iodine 2 % / sodium iodide 2.4 % 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
70000-0401-12024-05-13C16284748780-11030e365-2ef8-111a-e063-dadaa90a10e2LEADER 2% Mild Iodine Tincture
70000-0401-12024-01-30C16284748780-11030e365-2ef8-111a-e063-dadaa90a10e2LEADER 2% Mild Iodine Tincture

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0401-1LEADER 2% Mild Iodine Tincture30 mL in 1 BOTTLE, PLASTICLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0401LEADER 2% MILD IODINE TINCTURE (IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20240514_7f810b92-60f6-2f72-e053-2991aa0ab973.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0401-1ML - Milliliter70000-0401991c2419-4dc6-480a-89f9-187c53ec5be112019-08-06

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
70000-040170000-0401-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SODIUM IODIDEF5WR8N145CACTIM
IODINE9679TC07X4ACTIB

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 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
ndc (package): 70000-0401-1
ndc (product): 70000-0401
ndc11 (package): 70000040101
spl id: 1855b847-f240-9f78-e063-6394a90a3df3
spl set id: 7f810b92-60f6-2f72-e053-2991aa0ab973

Reported adverse events (FAERS/openFDA)#

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