Dandruff 

Dandruff 
SPL v1
SPL
SPL Set ID bb8128e0-c589-4ac6-902a-322d3ab6d512
Route
TOPICAL
Published
Effective Date 2024-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.5 g)
Inactive Ingredients
Water Sodium Lauryl Sulfate Cocamidopropyl Betaine Sodium Chloride Coco Monoethanolamide Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Glycerin Citric Acid Monohydrate Edetate Disodium Aloe Vera Leaf Methylchloroisothiazolinone Methylisothiazolinone Guar Hydroxypropyltrimonium Chloride Glycol Distearate Menthol, Unspecified Form Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-17

Description

Pyrithione zinc 0.5% W/V

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

Pyrithione zinc 0.5% W/V

Uses:

Helps prevent recurrence of flaking and itching associated with dandruff.

Section 42229-5

ALL HAIR TYPES

Helps to relieve itching, dryness and flakes

Distributed by:

Universal Distribution Center LLC

96 Distribution Boulevard, Edison, NJ 08817

www.universaldc.com

Made in India                                                                           

Section 50565-1

Keep out of reach of children.

Purpose:

Anti-dandruff

Packaging

Warnings:

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if Condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts

Directions:

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Active Ingredient:

Pyrithione zinc 0.5% W/V

Other Information:

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1


Structured Label Content

Uses:

Helps prevent recurrence of flaking and itching associated with dandruff.

Section 42229-5 (42229-5)

ALL HAIR TYPES

Helps to relieve itching, dryness and flakes

Distributed by:

Universal Distribution Center LLC

96 Distribution Boulevard, Edison, NJ 08817

www.universaldc.com

Made in India                                                                           

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose:

Anti-dandruff

Packaging

Warnings: (WARNINGS:)

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if Condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts

Directions:

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Active Ingredient:

Pyrithione zinc 0.5% W/V

Other Information:

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide Mea, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Fd & C Blue No.1


Advanced Ingredient Data


Raw Label Data

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