drug facts

drug facts
SPL v1
SPL
SPL Set ID b1482958-8370-43fc-8789-0f329bfe676a
Route
topical
Published
Effective Date 2013-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (10 mg)
Inactive Ingredients
water sodium laureth sulfate dihydrogenated tallow phthalic acid amide sodium chloride titanium dioxide cocamidopropyl betaine sodium stearoyl lactylate dimethicone citric acid monohydrate dmdm hydantoin sodium citrate aloe vera leaf hypromelloses fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-06-20
Purpose

ANTI-DANDRUFF

Description

SELENIUM SULFIDE 1%

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

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

Purpose

ANTI-DANDRUFF

Directions

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

Description

SELENIUM SULFIDE 1%

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

Questions/comments?

1-866-695-3030

Inactive Ingredients:

WATER (AQUA), SODIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE, SODIUM CHLORIDE, TITANIUM DIOXIDE, COCAMIDOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, FRAGRANCE (PARFUM), DIMETHICONE, CITRIC ACID, DMDM HYDANTOIN, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090).

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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

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

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, DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE, SODIUM CHLORIDE, TITANIUM DIOXIDE, COCAMIDOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, FRAGRANCE (PARFUM), DIMETHICONE, CITRIC ACID, DMDM HYDANTOIN, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090).

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: 2026-02-15T11:55:39.332109 · Updated: 2026-03-14T22:53:32.152302