Label: DANDRENE- pyrithione zinc lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 30, 2020

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  • PRINCIPAL DISPLAY PANEL

    die cutlabel

  • INGREDIENTS AND APPEARANCE
    DANDRENE 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72249-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
    ALCOHOL (UNII: 3K9958V90M)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72249-001-011 in 1 BOX10/16/2018
    1205 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only10/16/2018
    Labeler - Divine Skin Laboratories S.A. de C.V. (812464196)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(72249-001) , label(72249-001)
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