Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c5a7f1c9-42ac-4eef-8a40-da338329731c
Route
TOPICAL
Published
Effective Date 2013-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (10 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Triethanolamine Lauryl Sulfate Cocamidopropyl Betaine Citric Acid Monohydrate Ammonium Chloride Dmdm Hydantoin Sodium Hydroxide Menthol Magnesium Aluminum Silicate Hypromelloses Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-07-15
Description

SELENIUM SULFIDE 1%

Purpose

ANTI-DANDRUFF, ANTI-SEBORREIC DERMATITIS

Medication Information

Purpose

ANTI-DANDRUFF, ANTI-SEBORREIC DERMATITIS

Description

SELENIUM SULFIDE 1%

Uses

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RECURRENCE.

Warnings

FOR EXTERNAL USE ONLY.

Directions

SHAKE WELL. SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

Questions/comments?

1-866-695-3030

Inactive Ingredients:

WATER (AQUA), SODIUM LAURETH SULFATE, ACRYLATES COPOLYMER, TEA-LAURETH SULFATE, COCAMIDOPROPYL BETAINE, CITRIC ACID, AMMONIUM CHLORIDE, FRAGRANCE (PARFUM), DMDM HYDANTOIN, SODIUM HYDROXIDE, MENTHOL, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200).

When Using This Product

AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.

Stop Use and Ask A Doctor If

CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.

Keep Out of Reach of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Ask A Doctor Before Using If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

Structured Label Content

Uses (USES)

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RECURRENCE.

Purpose (PURPOSE)

ANTI-DANDRUFF, ANTI-SEBORREIC DERMATITIS

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

SHAKE WELL. SHAMPOO, THEN RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-695-3030

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), SODIUM LAURETH SULFATE, ACRYLATES COPOLYMER, TEA-LAURETH SULFATE, COCAMIDOPROPYL BETAINE, CITRIC ACID, AMMONIUM CHLORIDE, FRAGRANCE (PARFUM), DMDM HYDANTOIN, SODIUM HYDROXIDE, MENTHOL, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200).

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.

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 PRODUCT 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.

Ask A Doctor Before Using If You Have (ASK A DOCTOR BEFORE USING IF YOU HAVE)

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.044651 · Updated: 2026-03-14T22:53:32.846368