MARCS EVERYDAY CARE DANDRUFF ANTI-DANDRUFF- pyrithione zinc shampoo

Marcs Everyday Care Dandruff by

Drug Labeling and Warnings

Marcs Everyday Care Dandruff by is a Otc medication manufactured, distributed, or labeled by Mark Glassman, Inc., 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 of this product as directed

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

*Compare to the active
ingredient in Head & Shoulders®

Marcs®

pyrithione zinc

Dandruff
Shampoo

Everyday Care

Basic everyday cleaning
for normal hair

pyrithione zinc 1 %

13.5 FL OZ (399 mL)

INGREDIENTS AND APPEARANCE

MARCS EVERYDAY CARE DANDRUFF   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-134
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)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
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)
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: 68998-134-01	399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/30/2011

Labeler - Mark Glassman, Inc. (094487477)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(68998-134)