3d56d22d-0e83-bfae-e063-6294a90ab8bd

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

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

Purpose

Antidandruff agent

Description

Selenium disulfide 1%

Medication Information

Warnings

For external use only.

Flammable: Keep away from fire or flame

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

Inactive Ingredients

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

Description

Selenium disulfide 1%

Principal Display Panel

Uses:

• Treats and prevents dandruff

• Controls flaking and itching of the scalp

Do Not Use:

• On broken or inflamed skin

• In children under 3 years

• If allergic to selenium compounds

Active Ingredients

Selenium disulfide 1%

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

Warnings

For external use only.

Flammable: Keep away from fire or flame

Purpose

Antidandruff agent

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Uses:

• Treats and prevents dandruff

• Controls flaking and itching of the scalp

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%

When Using This Product: (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.)

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

[{"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM LAURYL SULFATE", "unii": "Q7AO2R1M0B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SELENIUM SULFIDE", "unii": "Z69D9E381Q", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SEA SALT", "unii": "87GE52P74G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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:": "• 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", "When using this product:": "• Avoid contact with eyes (if occurs, rinse immediately) • Discontinue use if vision changes occur", "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.", "Stop use and ask a doctor if:": "• Skin irritation or rash occurs • Condition worsens or persists after 8 weeks"}

Additional Information

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