LEADER MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo

Leader Medicated Dandruff by

Drug Labeling and Warnings

Leader Medicated Dandruff by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, Garcoa, Inc., Sigan Industries INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpose

Anti-seborrheic dermatitis, anti-dandruff

Uses

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

Warnings

For external use only

As a doctor before use if

• ♦ condition covers a large area of the body.

When using this product

• ♦ 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

• ♦ 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

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

Other information

store at room temperature

Inactive ingredients

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?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DIST BY CAH, DUBLIN, OH 43017

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

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

INGREDIENTS AND APPEARANCE

LEADER MEDICATED DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0531
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q)	Selenium Sulfide	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0531-1	207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/05/2019

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(70000-0531)