Revox

Revox
SPL v1
SPL
SPL Set ID 1cf8e1fd-8324-4b1b-b3b8-5c397505049e
Route
TOPICAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Coco Diethanolamide Betula Pubescens Leaf Chamomile Millet Sage Urtica Dioica Leaf Equisetum Arvense Branch Hops Cinchona Pubescens Bark Green Tea Leaf Tilia Cordata Flower Panthenol Niacin Biotin Sodium Chloride Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Cananga Oil Dexpanthenol Aloe Vera Leaf Echinacea Purpurea Calendula Officinalis Flower Centella Asiatica Melissa Officinalis Leaf Hamamelis Virginiana Leaf Benzyl Alcohol Propylene Glycol Methylchloroisothiazolinone Methylisothiazolinone Vitis Vinifera Seed Polyoxyl 40 Hydrogenated Castor Oil Tocopherol Pea Edetate Sodium Anhydrous Citric Acid Coumarin Linalool, (+/-)- Methyl-.alpha.-ionone Linalyl Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-30

Description

Zinc Pyrithione


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

To prevent Dandruff

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

Dosage and Administration

Massage into scalp and hair. Rinse. 

Description

Zinc Pyrithione

Section 50565-1

Keep out of reach of children

Section 55105-1

Anti-dandruff

Packaging

Active Ingredient

Zinc Pyrithione

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.


Structured Label Content

Indications and Usage (34067-9)

To prevent Dandruff

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

Dosage and Administration (34068-7)

Massage into scalp and hair. Rinse. 

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

Section 55105-1 (55105-1)

Anti-dandruff

Packaging

Active Ingredient

Zinc Pyrithione

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.


Advanced Ingredient Data


Raw Label Data

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