FDA.reportPublic FDA data

Salicylic Acid - CARDINAL HEALTH 110, LLC. DBA LEADER | Medical Group Care LLC

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Medical Group Care LLC
Effective date
2026-09-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-11 03:01:09

Label at a glance#

ProductLeader Maximum Strength Therapeutic Dandruff
Active ingredientSALICYLIC ACID
Label structure12 sections

Indications and uses

helps to stop the symptoms of these conditions and their recurrence: ▪ irritation ▪ itching ▪ redness ▪ flaking ▪ scaling

Dosage and administration

▪ wet hair, massage onto scalp, rinse and repeat if desired ▪ for best results use at least twice a week or as directed by a doctor ▪ for maximum dandruff control, use every time when you want to shampoo

Storage and handling

store away from direct sunlight, excessive heat, and freezing conditions

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 3%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-psoriasis, and Anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

helps to stop the symptoms of these conditions and their recurrence: ▪ irritation ▪ itching ▪ redness ▪ flaking ▪ scaling

WARNINGS SECTION

Warnings  For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a condition that 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.

Stop use and ask 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 the reach of children. If swallowed, get medical help or contact a Poison Control
Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ wet hair, massage onto scalp, rinse and repeat if desired
▪ for best results use at least twice a week or as directed by a doctor
▪ for maximum dandruff control, use every time when you want to shampoo

Other information

STORAGE AND HANDLING SECTION

store away from direct sunlight, excessive heat, and freezing conditions

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl
Betaine, Hexylene Glycol, Sodium Citrate, Polyquaternium-22, Polyquaternium-10,
Citric Acid

OTC - QUESTIONS SECTION

Questions? 866-306-9136
You may also report serious side effects to this phone number.
Monday-Friday 9 AM - 5 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ShampooShampoo

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-077670000-0776-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
POLYQUATERNIUM-22 (4500 MPA.S)H3W1D31JARIACT
CITRIC ACID2968PHW8QPIACT

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 Maximum Strength Therapeutic DandruffSALICYLIC ACIDCARDINAL HEALTH 110, LLC. DBA LEADER5afb2260-5b50-de95-e063-6394a90a5a472026-09-08WarningsExact identifier
ndc (package): 70000-0776-1
ndc (product): 70000-0776
ndc11 (package): 70000077601
spl id: 5afb2268-8b65-da85-e063-6394a90a6e30
spl set id: 5afb2260-5b50-de95-e063-6394a90a5a47

Reported adverse events (FAERS/openFDA)#

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