drug facts

drug facts
SPL v1
SPL
SPL Set ID 1004a6cb-2fbe-4822-800a-4f7296a82ed2
Route
topical
Published
Effective Date 2014-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (10 mg)
Inactive Ingredients
water ammonium laureth-3 sulfate ammonium lauryl sulfate glycol distearate coco monoethanolamide ammonium xylenesulfonate methacrylic acid - methyl methacrylate copolymer (1:1) sodium hydroxide sodium citrate dimethicone cetyl alcohol sodium chloride citric acid monohydrate sodium benzoate stearyl alcohol edetate disodium hypromelloses methylchloroisothiazolinone methylisothiazolinone fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-07-28
Purpose

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Description

SELENIUM SULFIDE 1%

Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS

Purpose

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Directions

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

Inactive Ingredients

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)

Description

SELENIUM SULFIDE 1%

Section 50565-1

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

When Using This Product

AVOID CONTACT WITH 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

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)

HELPS PREVENT THE CHANCE OF RECURRENCE OF FLAKING, ITCHING, IRRITATION, SCALING AND REDNESS ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS

Purpose (PURPOSE)

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Directions (DIRECTIONS)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)

Section 50565-1 (50565-1)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH 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

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: 2026-02-15T11:55:48.921431 · Updated: 2026-03-14T22:53:46.796959