Label: REVOX- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

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 January 30, 2018

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  • Active Ingredient

    Zinc Pyrithione

  • PURPOSE

    Anti-dandruff

  • INDICATIONS & USAGE

    To prevent Dandruff

    Prevents potential scaly and dryness on scalp up to 100% through anti-irritation property.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • WARNINGS

    For external use only

  • DOSAGE & ADMINISTRATION

    Massage into scalp and hair. Rinse. 

  • Inactive Ingredients

    Aqua, Sodium Lauryl Ether Sulfate, Cocoamido Propyl Betaine, Polyquarternium 7, Cocamide DEA, Betula Alba Leaf Ext., Chamomilla Recutita Flower Ext., Panicum Miliaceum Seed Ext., Salvia Officinalis Leaf Ext., Urtica Dioica Leaf Ext., Equisetum Arvense Ext., Humulus Lupulus Ext., Cinchona Succirubra Bark Ext., Camelia Sinensis Leaf Ext., Tilia Cordata Flower Ext., Panthenol, Niacin, Biotin , Sodium Chloride, Equisetum Arvense Ext., Hydrolyzed Wheat Protein, Ylang Ylang, D-Panthenol, Aloe Barbadensis Leaf Ext., Echinacea Purpurea Ext., Chamomilla Recutita Flower Ext., Calendula Officinalis Flower Ext., Centella Asiatica Ext., Melissa Officinalis Leaf Ext., Hamamelis Virginiana Leaf Ext., Tilia Cordata Flower Ext., Benzyl Alcohol, Propylene Glycol-Methylcloroisothiazolinone- Methylisothiazolinone, Vitis Vinifera (Grape) Seed Ext., PEG- 40 Hydrogenated Castor Oil, Tocopherol, Pisum Sativum Sprout Ext., Tetra Sodium E.D.T.A, Citric Acid, Coumarin, Linalool, Methyl Alpha- Ionone Isomer, Linalyl Acetate.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    REVOX 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72029-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MILLET (UNII: TJR6B3R47P)  
    SAGE (UNII: 065C5D077J)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    HOPS (UNII: 01G73H6H83)  
    CINCHONA PUBESCENS BARK (UNII: S96N10R972)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACIN (UNII: 2679MF687A)  
    BIOTIN (UNII: 6SO6U10H04)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PEA (UNII: W4X7H8GYFM)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYL-.ALPHA.-IONONE (UNII: QMK5X3FBG7)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72029-001-011 in 1 CARTON01/30/2018
    1400 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/30/2018
    Labeler - GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI (505204333)
    Establishment
    NameAddressID/FEIBusiness Operations
    GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI505204333manufacture(72029-001)