AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL- pyrithione zinc shampoo 
Colomer USA, Ltd.

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® Anti-Dandruff + Sebum Control Shampoo

Drug Facts

Active Ingredients

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

Controls itching & flaking due to dandruff.

Warnings

  • If condition worsens or does not improve after regular use of this product as directed, consult a physician.
  • Consult a physician prior to use in children under 2 years of age.

  • KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Aqua (Water) (Eau), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Glycerin, PEG-12 Dimethicone, Di-PPG-2 Myreth-10 Adipate, Triethanolamine, Hydroxyethylcellulose, Propylene Glycol, Sodium Chloride, Polyquaternium-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Acetate, Parfum (Fragrance), Limonene, Phenoxyethanol, Ethylparaben, Methylparaben, Methylchloroisothiazolinone, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL - 250mL Bottle Label

AMERICAN
CREW
®
TRICHOLOLGY

Official Supplier to Men™

ANTI-DANDRUFF +
SEBUM CONTROL
SHAMPOO

Anti-dandruff + sebum
control shampoo with
conditioning properties

250mL e / 8.4 Fl. Oz.

Principal Display Panel - 250mL Bottle Label
AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42743-4700
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ROSEMARY (UNII: IJ67X351P9)  
SAGE (UNII: 065C5D077J)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42743-4700-1250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H08/31/2013
Labeler - Colomer USA, Ltd. (137750993)
Establishment
NameAddressID/FEIBusiness Operations
Tri Tech Laboratories792844680MANUFACTURE(42743-4700) , PACK(42743-4700)

Revised: 6/2014
Document Id: 605ebeb6-c4ad-4c3e-8a6d-e15b63041dda
Set id: 7e62cb98-d03d-4091-824b-7406583d871f
Version: 2
Effective Time: 20140611
 
Colomer USA, Ltd.