SPL v5
SPL
SPL Set ID 54b0a610-dd15-4064-9feb-4d30b5e522ad
Route
TOPICAL
Published
Effective Date 2022-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (2 g)
Inactive Ingredients
Water Disodium Laureth Sulfosuccinate Trolamine Glycolic Acid Coco Monoethanolamide Sodium Lauroyl Sarcosinate Sodium Lauryl Sulfoacetate Glycol Distearate Peg-150 Distearate Magnesium Aluminum Silicate Sodium Citrate Hexamidine Diisethionate Surinamine Caprylyl Glycol Phenoxyethanol Butylene Glycol Punica Granatum Flower Rosemary Shikimic Acid Tioxolone Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01
Description

Zinc Pyrithione 2%

Purpose

Anti-dandruff

Medication Information

Purpose

Anti-dandruff

Description

Zinc Pyrithione 2%

Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Section 50565-1

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 minutes, rinse 

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

Product Label

Active Ingredient

Zinc Pyrithione 2%

Inactive Ingredients

Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine

Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

Structured Label Content

Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff 

Section 50565-1 (50565-1)

Purpose

Anti-dandruff

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Directions

Apply shampoo to wet hair and scalp with gentle massage, leave in for 2-3 minutes, rinse 

For best results use atleast 2 times per week or as direacted by a doctor

For maximum benefits use 4-5 times a week along with Dandrene anti-dandruff conditioner

Product Label (Product label)

Active Ingredient (Active ingredient)

Zinc Pyrithione 2%

Inactive Ingredients (Inactive ingredients)

Water, Disodium Laureth Sulfosuccinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Sodium Lauroyl Sarcosinate, Sodium Lauryl Suloacetate, Glycol Distearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine

Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Punica Granatum Extract, Rosmarinus Officinalis Leaf Extract, Shikimic Acid, Tioxolone, Blue 1

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.482964 · Updated: 2026-03-14T23:13:34.159935