SPL v1
SPL
SPL Set ID 3d56d22d-0e83-bfae-e063-6294a90ab8bd
Route
TOPICAL
Published
Effective Date 2025-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (1 g)
Inactive Ingredients
Tocopherol Ammonium Lauryl Sulfate Water Sea Salt Phenoxyethanol Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-26
Description

Selenium disulfide 1%

Purpose

Antidandruff agent

Dosage and Administration

​Adults and children 3 years and older:​​ Wet hair thoroughly Apply amount to cover scalp (approx. 1 teaspoon) Massage 3-5 minutes until lather forms Rinse completely with water Repeat twice weekly Children under 3 years:​​ Do not use

Medication Information

Purpose

Antidandruff agent

Dosage and Administration

​Adults and children 3 years and older:​​

Wet hair thoroughly

Apply amount to cover scalp (approx. 1 teaspoon)

Massage 3-5 minutes until lather forms

Rinse completely with water

Repeat twice weekly

Children under 3 years:​​ Do not use

Description

Selenium disulfide 1%

Uses:

• Treats and prevents dandruff

• Controls flaking and itching of the scalp

Warnings

For external use only.

Flammable: Keep away from fire or flame

Do Not Use:

• On broken or inflamed skin

• In children under 3 years

• If allergic to selenium compounds

Active Ingredients

Selenium disulfide 1%

Inactive Ingredients

Water, Ammonium Lauryl Sulfate, Citric Acid, Sea Salt, Phenoxyethanol, Tocopherols

Principal Display Panel

When Using This Product:

• Avoid contact with eyes (if occurs, rinse immediately)

• Discontinue use if vision changes occur

Keep Out of Reach of Children.

Keep out of reach of children.​

Stop Use and Ask A Doctor If:​

• Skin irritation or rash occurs

• Condition worsens or persists after 8 weeks

Structured Label Content

Uses:

• Treats and prevents dandruff

• Controls flaking and itching of the scalp

Purpose

Antidandruff agent

Warnings

For external use only.

Flammable: Keep away from fire or flame

Do Not Use: (Do NOT use:)

• On broken or inflamed skin

• In children under 3 years

• If allergic to selenium compounds

Active Ingredients (Active ingredients)

Selenium disulfide 1%

Inactive Ingredients (Inactive ingredients)

Water, Ammonium Lauryl Sulfate, Citric Acid, Sea Salt, Phenoxyethanol, Tocopherols

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product: (When using this product:)

• Avoid contact with eyes (if occurs, rinse immediately)

• Discontinue use if vision changes occur

Dosage and Administration (Dosage and administration)

​Adults and children 3 years and older:​​

Wet hair thoroughly

Apply amount to cover scalp (approx. 1 teaspoon)

Massage 3-5 minutes until lather forms

Rinse completely with water

Repeat twice weekly

Children under 3 years:​​ Do not use

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

Keep out of reach of children.​

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

• Skin irritation or rash occurs

• Condition worsens or persists after 8 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:52.364879 · Updated: 2026-03-14T23:09:53.979552