SPL v1
SPL
SPL Set ID 3344c97b-8767-3f87-e063-6394a90a4f5d
Route
TOPICAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.5 g)
Inactive Ingredients
Cocamide Mea Glycerin Cocamidopropyl Betaine Calcium Chloride Water Edetate Disodium Sodium Laureth Sulfate Methylisothiazolinone Citric Acid Zinc Chloride Blue 1 Aloe Barbadensis Leaf Yellow 5 Gellan Gum Sodium Chloride Methylchloroisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

Description

Pyrithione Zinc 0.5%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff

Description

Pyrithione Zinc 0.5%

Use



Helps prevent recurrence of flaking and itching associsted with dandruff.

Label

Warnings



For external use only

Directions

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

Active Ingredient

Pyrithione Zinc 0.5%

Other Information

Store at room temperature.

Inactive Ingredients



Water

Sodium Laureth Sulfate

Cocamidopropyl Betaine

Sodium Chloride

Cocamide MEA

Fragrance

Gellan Gum

Citric Acid

Zinc Chloride

Calcium Chloride

Glycerin

Disodium EDTA

Aloe Barbadensis Leaf Extract

Methylchloroisothiazolinone

Methylisothiazolinone

Yellow 5

Blue 1

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 products as directed.

Keep Out of Reach of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use



Helps prevent recurrence of flaking and itching associsted with dandruff.

Label

Purpose

Anti-dandruff

Warnings



For external use only

Directions

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

Active Ingredient (Active ingredient)

Pyrithione Zinc 0.5%

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)



Water

Sodium Laureth Sulfate

Cocamidopropyl Betaine

Sodium Chloride

Cocamide MEA

Fragrance

Gellan Gum

Citric Acid

Zinc Chloride

Calcium Chloride

Glycerin

Disodium EDTA

Aloe Barbadensis Leaf Extract

Methylchloroisothiazolinone

Methylisothiazolinone

Yellow 5

Blue 1

When Using This Product (When using this product)



Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)



Condition worsens or does not improve after regular use of this products as directed.

Keep Out of Reach of Children (Keep out of reach of children)



If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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