AMERICAN CREW- pyrithione zinc shampoo 
Colomer USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AMERICAN
CREW®
CLASSIC
ANTI-DANDRUFF
SHAMPOO

Drug Facts

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 - 250mL Bottle Label

AMERICAN
CREW®
CLASSIC

ANTI-DANDRUFF
SHAMPOO

Anti-dandruff shampoo
with pyrithione zinc

Shampooing anti-pelliculaire
au zinc pyrithione

02310155

250mL / 8.4 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 250mL Bottle Label
AMERICAN CREW 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42743-9104
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc0.01 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42743-9104-1250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H07/31/2008
Labeler - Colomer USA (137750993)
Establishment
NameAddressID/FEIBusiness Operations
Colomer USA, Ltd.137750993MANUFACTURE, PACK

Revised: 9/2011
Document Id: 325aa8b8-e20c-4e5d-98fb-c9380c3b331e
Set id: 3d9b14ef-fc69-4841-a444-e040c816e5de
Version: 2
Effective Time: 20110926
 
Colomer USA