REVOX- pyrithione zinc shampoo

REVOX by

Drug Labeling and Warnings

REVOX by is a Otc medication manufactured, distributed, or labeled by GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

REVOX 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72029-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72029-001-01	1 in 1 CARTON	01/30/2018
1		400 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/30/2018

Labeler - GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI (505204333)

Establishment
Name	Address	ID/FEI	Business Operations
GEOMASS ARASTIRMA GELISTIRME ENERJI PETROL MADEN SIS ILAC VE KOZ URUN IM SAN TIC LTD STI		505204333	manufacture(72029-001)