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

Description

Selenium Sulfide 1%

Purpose

Anti-dandruff


Medication Information

Purpose

Anti-dandruff



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,



Warnings

For external use only



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









Do Not Use

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



Other Information

store at 20°C to 25°C (68°F-77°F)

see bottom panel for expiration date



Active Ingredient(s)

Selenium Sulfide 1%

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



Package Label Principal Display Panel


Structured Label Content

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,



Purpose

Anti-dandruff



Warnings

For external use only



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









Do Not Use (Do not use)

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



Other Information (Other information)

store at 20°C to 25°C (68°F-77°F)

see bottom panel for expiration date



Active Ingredient(s)

Selenium Sulfide 1%

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



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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)