LEADER DANDRUFF EVERYDAY CLEAN ANTI-DANDRUFF- pyrithione zinc shampoo

Leader Dandruff Everyday Clean by

Drug Labeling and Warnings

Leader Dandruff Everyday Clean 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

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

• ♦ do not get into 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 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
• ♦ wet hair
• ♦ massage onto scalp
• ♦ rinse
• ♦ 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 you shampoo

Other information

store at room temperature

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OH 43017

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

LEADER™

NDC: 70000-0533-1

Dandruff
Shampoo

Pyrithione Zinc, 1%
Anti-Dandruff

Everyday
Clean

Basic Everyday
Cleaning for
Normal Hair

COMPARE TO
HEAD &
SHOULDERS®
active ingredient*

100% Money
Back Guarantee

14.2 FL OZ (420 mL)

05-3789

INGREDIENTS AND APPEARANCE

LEADER DANDRUFF EVERYDAY CLEAN   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0533
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Coco Monoethanolamide (UNII: C80684146D)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Glycol Distearate (UNII: 13W7MDN21W)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Sodium Benzoate (UNII: OJ245FE5EU)
Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)
Ammonium Laureth-5 Sulfate (UNII: 43ZIH89I48)
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Chloride (UNII: 451W47IQ8X)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Sodium Xylenesulfonate (UNII: G4LZF950UR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Red No. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0533-1	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	10/10/2019

Labeler - Cardinal Health (097537435)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan America, LLC		964976968	MANUFACTURE(70000-0533)