85724-001

85724-001
SPL v1
SPL
SPL Set ID 36a5efa8-0617-868d-e063-6394a90a1705
Route
topical
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (1 g)
Inactive Ingredients
ginger menthol panthenol sodium hyaluronate polyquaternium-10 (125 mpa.s at 2%) zinc pca aconitic acid aqua decyl glucoside sodium c14-16 olefin sulfonate cocamidopropyl betaine glycerin glycol stearate sodium benzoate phenoxyethanol platycladus orientalis leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-03

Purpose

Anti-dandruff

Description

Selenium Sulfide 1%


Medication Information

Warnings

For external use only



Purpose

Anti-dandruff



Directions

adults and children 12 years and over

1. wet hair thoroughly

2. apply shampoo, generously lather, rinse thoroughly. Repeat

3. use every 3-4 days for up to 8 weeks or as directed by a doctor, Then use only as needed to control dandruff

children under 12 years

1. ask a doctor









Other Information

store at 20°C to 25°C (68°F-77°F)

see bottom panel for expiration date



Inactive Ingredients

Aqua,DecyI Glucoside, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerol, Glycol Stearate, Sodium

Benzoate, Phenoxyethanol, Thuja Orientalis Leaf Extract, Ginger Root Extract, Panthenol, Menthol, Polyquaternium-10,

Zinc Pca, Sodium Hyaluronate, Citric Acid



Description

Selenium Sulfide 1%

Use

Controls the symptoms of:

dandruff, seborheic dermatitis, psoriasis.



Section 50565-1

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center (1-800-222-1222) right away,



Section 50566-9

rash appears

condition worsens or does not improve in 2-4 weeks



Section 50567-7

avoid contact with the eyes. If contact occurs,rinse eyes

thoroughly with water,



Do Not Use

If pregnant or breast-feeding, ask a doctor before use.



Active Ingredient(s)

Selenium Sulfide 1%

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only



Purpose

Anti-dandruff



Directions

adults and children 12 years and over

1. wet hair thoroughly

2. apply shampoo, generously lather, rinse thoroughly. Repeat

3. use every 3-4 days for up to 8 weeks or as directed by a doctor, Then use only as needed to control dandruff

children under 12 years

1. ask a doctor









Other Information (Other information)

store at 20°C to 25°C (68°F-77°F)

see bottom panel for expiration date



Inactive Ingredients (Inactive ingredients)

Aqua,DecyI Glucoside, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerol, Glycol Stearate, Sodium

Benzoate, Phenoxyethanol, Thuja Orientalis Leaf Extract, Ginger Root Extract, Panthenol, Menthol, Polyquaternium-10,

Zinc Pca, Sodium Hyaluronate, Citric Acid



Use

Controls the symptoms of:

dandruff, seborheic dermatitis, psoriasis.



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or

contact a Poison Control Center (1-800-222-1222) right away,



Section 50566-9 (50566-9)

rash appears

condition worsens or does not improve in 2-4 weeks



Section 50567-7 (50567-7)

avoid contact with the eyes. If contact occurs,rinse eyes

thoroughly with water,



Do Not Use (Do not use)

If pregnant or breast-feeding, ask a doctor before use.



Active Ingredient(s)

Selenium Sulfide 1%

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)