LEADER MEDICATED DANDRUFF  ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo 
Cardinal Health, 110 dba LEADER

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Leader™ Medicated Dandruff Shampoo
Anti-Seborrheic Dermatitis, Anti-Dandruff

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

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

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label
LEADER MEDICATED DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0531
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q) Selenium Sulfide10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0531-1207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM03211/05/2019
Labeler - Cardinal Health, 110 dba LEADER (063997360)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC255106239MANUFACTURE(70000-0531)

Revised: 3/2024
Document Id: 41bfe5c0-8c9b-4860-a3c7-453e5e9106f1
Set id: 3f64a2ef-a415-49b0-bf14-eb4da66d511f
Version: 4
Effective Time: 20240313
 
Cardinal Health, 110 dba LEADER