Label: AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 11, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Pyrithione Zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    Controls itching & flaking due to dandruff.

  • Warnings

    • For external use only.
    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    • 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

    • 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

    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
  • INGREDIENTS AND APPEARANCE
    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)
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