MARCS DRY SCALP CARE DANDRUFF ANTI-DANDRUFF- pyrithione zinc shampoo

Marcs Dry Scalp Care Dandruff by

Drug Labeling and Warnings

Marcs Dry Scalp 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, prunus amygdalus dulcis (sweet almond) oil, cetyl alcohol, polyquaternium-10, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid

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

Dry Scalp Care

Moisturizing formula for
dryness & itch relief

pyrithione zinc 1 %

05-1928B

13.5 FL OZ (399 mL)

INGREDIENTS AND APPEARANCE

MARCS DRY SCALP CARE DANDRUFF   ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-133
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)
ALMOND OIL (UNII: 66YXD4DKO9)
Cetyl Alcohol (UNII: 936JST6JCN)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-133-01	399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/04/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	10/04/2013

Labeler - Mark Glassman, Inc. (094487477)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(68998-133)