FDA.reportPublic FDA data

Leader Medicated Dandruff

Manufacturer
Cardinal Health, 110 dba LEADER | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-03-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:07

Label at a glance#

ProductLeader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff
Active ingredientSelenium Sulfide
Label structure11 sections

Indications and uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

Dosage and administration

shake well shampoo, then rinse thoroughly for best results, use at least twice a week or as directed by a doctor.

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium Sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-seborrheic dermatitis, anti-dandruff

Uses

INDICATIONS & USAGE SECTION

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

WARNINGS SECTION

For external use only

As a doctor before use if

OTC - ASK DOCTOR SECTION

  • condition covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
  • for color-treated or permed hair, rinse thoroughly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use of this product as directed.

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) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • shampoo, then rinse thoroughly
  • for best results, use at least twice a week or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33

Questions or comments?

OTC - QUESTIONS SECTION

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST BY CAH, DUBLIN, OH 43017

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0531-1

Medicated
Dandruff
Shampoo

Selenium Sulfide, 1%
Anti-Seborrheic Dermatitis
Anti-Dandruff

With Menthol

For the Relief
of Seborrheic
Dermatitis
and Dandruff
Symptoms

COMPARE TO
SELSUN BLUE®
active ingredient*

100% Money
Back Guarantee

7 FL OZ (207 mL)

05-3793

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN5
204642selenium sulfide 10 MG/ML Medicated ShampooSCD5
204642selenium sulfide 1 % Lotion ShampooSY5
204642selenium sulfide 1 % Medicated ShampooSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0531-1Leader Medicated DandruffAnti-Seborrheic Dermatitis, Anti-Dandruff207 mL in 1 BOTTLE, PLASTICSHAMPOO2075

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0531-1ML - Milliliter70000-05315dbcf65b-8058-47e7-9cf8-33afeb5b33cc12020-07-13

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-053170000-0531-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Selenium SulfideZ69D9E381QACTIB
Water059QF0KO0RIACT
AMMONIUM LAURETH-5 SULFATE43ZIH89I48IACT
Ammonium Lauryl SulfateQ7AO2R1M0BIACT
COCO MONOETHANOLAMIDEC80684146DIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
ChlorphenesinI670DAL4SZIACT
PhenoxyethanolHIE492ZZ3TIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Sodium Chloride451W47IQ8XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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 Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-DandruffSELENIUM SULFIDECardinal Health, 110 dba LEADER3f64a2ef-a415-49b0-bf14-eb4da66d511f2024-03-13WarningsExact identifier
ndc (package): 70000-0531-1
ndc (product): 70000-0531
ndc11 (package): 70000053101
spl id: 8fce31c4-f08b-4c6f-96ea-59f59add8cfe
spl set id: 3f64a2ef-a415-49b0-bf14-eb4da66d511f

Reported adverse events (FAERS/openFDA)#

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