Active Ingredients

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

Controls itching and flaking due to dandruff.

Warnings

For External Use Only

Avoid contact with 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.

Consult a doctor prior to use in children under 2 years old.

KEEP OUT OF REACH OF CHILDREN.

Directions

Wet hair thoroughly.
Massage a small amount of shampoo evenly into scalp and leave on for a few minutes. Rinse well.
For best results use at least twice a week or as directed by a physician.

Inactive Ingredients

Water (Aqua) (Eau), Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Lauramide DEA, Tromethamine Magnesium, Aluminum Silicate, Hydroxypropyl Methylcellulose, Citric Acid, Sodium Chloride, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Limonene, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Green 5 (CI 61570).

For product comments mail inquiries to: 1515 Wazee, Suite 200, Denver CO, 80202

PRINCIPAL DISPLAY PANEL - 250 mL bottle label

AMERICAN
CREW®
CLASSIC

ANTI-DANDRUFF
SHAMPOO

Pyrithione Zinc Shampoo
Dry Scalp Treatment

02310155

250 mL/8.45 Fl. Oz. e

PRINCIPAL DISPLAY PANEL - 250 mL bottle label

AMERICAN CREW
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	42743-9104
Route of Administration	CUTANEOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (Pyrithione Zinc)	Pyrithione Zinc	0.01 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
SODIUM LAURYL SULFATE
SODIUM LAURETH SULFATE
LAURIC DIETHANOLAMIDE
ALUMINUM SILICATE
HYPROMELLOSE 2208 (100 MPA.S)
ANHYDROUS CITRIC ACID
SODIUM CHLORIDE
SPEARMINT OIL
MENTHOL
LIMONENE, (+)-
METHYLPARABEN
PROPYLPARABEN
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
D&C GREEN NO. 5

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42743-9104-1	250 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	07/31/2008

Labeler - Colomer USA, Ltd. (137750993)

Establishment
Name	Address	ID/FEI	Operations
Colomer USA, Ltd.		137750993	MANUFACTURE, PACK

Revised: 12/2010Colomer USA, Ltd.