Label: ANTIDANDRUFFSHAMPOO- pyrithione zinc shampoo 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 21, 2016

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  • PRINCIPAL DISPLAY PANEL

    Arganicare PDP

    Zinc Pyrithione 1.0%

    Controls Dandruff

    Keep out of reach of children.

    Controls itching and flaking associated with dandruff

    For external use only. Avoid contact with eyes. If contact occurs, rinse eyes throughly with water. If condition worsens or does not improve after regular use of this product as directed, consult a doctor.

    Wet hair, apply shampoo and work into a lather. Rinse thoroughly with warm water. For best results, use at least twice a week or as direct by a doctor.

  • INGREDIENTS AND APPEARANCE
    ANTIDANDRUFFSHAMPOO 
    pyrithione zinc shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-12 SULFATE (UNII: E1ZP93931S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) (UNII: 2RX4MI2LCX)  
    SHEANUT OIL (UNII: O88E196QRF)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1608-1400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/23/2016
    Labeler - Peer Pharm Ltd. (514678390)
    Registrant - Peer Pharm Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(69435-1608)
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