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

Leader Therapeutic Dandruff by

Drug Labeling and Warnings

Leader Therapeutic Dandruff by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, Garcoa, Inc., SV Labs Toronto Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 laureth sulfate, cocamidopropyl betaine, cocamide MEA, sodium C14-16 olefin sulfonate, polyquaternium-7, propylene glycol, PEG-150 distearate, sodium citrate, triethanolamine.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

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)

05-3791A

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0550-1	133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	12/27/2019

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(70000-0550)