FDA.reportPublic FDA data

LEADER Mild Iodine

Manufacturer
Cardinal Health | Humco Holding Group, Inc.
Effective date
2020-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:40:59

Label at a glance#

ProductLEADER Mild Iodine
Active ingredientIODINE, SODIUM IODIDE, ALCOHOL
Label structure11 sections

Indications and uses

 To help prevent infection in minor cuts, scrapes and burns.

Dosage and administration

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

Storage and handling

Will stain skin and clothing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine 2%
Sodium Iodide 2.4%
Alcohol 47%


Purpose

OTC - PURPOSE SECTION

  • Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  •  To help prevent infection in minor cuts, scrapes and burns.

Warnings: For external use only.

WARNINGS SECTION

Ask a doctor before use if you have

  • deep or puncture  wounds
  • animal bites
  • serious burns.

Stop use and ask a doctor if

  • the condition persists or gets worse, or if using this product for longer than 1 week.

When using this product:

OTC - WHEN USING SECTION

  • do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids
  • do not apply over large areas of the body.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion. Give milk, then give a starch solution made by mixing two tablespoonfuls of cornstarch or flour to a pint of water. Contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean the affected area.

Apply a small amount to th affected area 1 to 3 times daily. May be covered with a sterile bandage.

If bandaged, let dry first.

Other Information:

STORAGE AND HANDLING SECTION

Will stain skin and clothing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water.

Distributed by: Cardinal Health Dublin, Ohio 43017 1-800-200-6313 www.myleader.com

SPL UNCLASSIFIED SECTION

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

LEADER 2% Mild Iodine Tincture USP 1oz/30ml (37205-022-10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IodineTinctureIodineTincture

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-022-102020-02-19C16284748780-19d75b9d0-ef6e-f424-e053-dadaa90a57ceLEADER 2% Mild Iodine Tincture USP
37205-022-102020-01-31C16284748780-19d75b9d0-ef6e-f424-e053-dadaa90a57ceLEADER 2% Mild Iodine Tincture USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-022-10ML - Milliliter37205-022c56c764e-5cfa-484e-aa9a-2377ada70a4112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90M2
IODINEACTIVE INGREDIENT9679TC07X42
SODIUM IODIDEACTIVE INGREDIENTF5WR8N145C2
ALCOHOLACTIVE MOIETY3K9958V90M2
IODIDE IONACTIVE MOIETY09G4I6V86Q2
IODINEACTIVE MOIETY9679TC07X42
WATERINACTIVE INGREDIENT059QF0KO0R2

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
37205-02237205-022-10

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
IODINE9679TC07X4ACTIB
SODIUM IODIDEF5WR8N145CACTIM
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML · Source PDF

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
e428c523-aa89-8d4e-e053-2995a90aead6f79ec553-4b96-46f7-b620-af9ac9673c412022-07-19WarningsExact identifier
spl set id: f79ec553-4b96-46f7-b620-af9ac9673c41

Reported adverse events (FAERS/openFDA)#

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