LEADER THERAPEUTIC DANDRUFF  ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS- salicylic acid shampoo 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader™ Therapeutic Dandruff Shampoo
Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis

Drug Facts

Active ingredient

Salicylic Acid 3.0%

Purpose

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

Uses

control the symptoms of

⬥
dandruff
⬥
seborrheic dermatitis
⬥
psoriasis

Warnings

For external use only

Ask a doctor before use if you have a condition which covers a large area of the body.

When using this product

⬥
avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

⬥
for best results use at least twice a week or as directed by a doctor
⬥
wet hair thoroughly
⬥
massage shampoo into scalp
⬥
lather, leave on hair and scalp for several minutes
⬥
rinse and repeat.

Other information

⬥
store at room temperature
⬥
store away from direct sunlight.

Inactive ingredients

water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide.

Questions or comments?

1-866-567-8600

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

LEADER™

NDC 70000-0550-1

Therapeutic
Dandruff
Shampoo

Salicylic Acid, 3%
Anti-Dandruff
Anti-Seborrheic Dermatitis
Anti-Psoriasis

Controls the
Symptoms of Psoriasis,
Seborrheic Dermatitis
& Dandruff
Clears & Helps Prevent
Scalp Buildup
Fragrance-Free
Dye-Free
Preservative-Free

COMPARE TO
NEUTROGENA® T/SAL®
active ingredient*

100% Money Back Guarantee

4.5 FL OZ (133 mL)

05-3791B

Principal Display Panel - 133 mL Bottle Label
LEADER THERAPEUTIC DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS
salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
Propylene Glycol (UNII: 6DC9Q167V3)  
PEG-150 Distearate (UNII: 6F36Q0I0AC)  
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0550-1133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H08/30/2022
Labeler - Cardinal Health (063997360)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC255106239MANUFACTURE(70000-0550)

Revised: 9/2022
Document Id: 782516f2-a194-4e9f-aaea-f44a4d3c6a20
Set id: 509434a9-50c4-4337-8e5b-17bdc667d23b
Version: 3
Effective Time: 20220906
 
Cardinal Health