REVOX- pyrithione zinc shampoo 
GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI

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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REVOX

Active Ingredient

Zinc Pyrithione

Anti-dandruff

To prevent Dandruff

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

Keep out of reach of children

For external use only

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

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)

Revised: 1/2018
Document Id: 2e2c03c4-6d17-46dd-8225-695619f31f26
Set id: 1cf8e1fd-8324-4b1b-b3b8-5c397505049e
Version: 1
Effective Time: 20180130
 
GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI