Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2e526dfa-6c77-4074-89a1-f94e7f778259
Route
TOPICAL
Published
Effective Date 2014-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-25

Description

SELENIUM SULFIDE 1%

Purpose

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS


Medication Information

Purpose

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Description

SELENIUM SULFIDE 1%

Uses

FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

Warnings

FOR EXTERNAL USE ONLY

Directions

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

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

Inactive Ingredients

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

Questions Or Comments?

1-888-723-3929

When Using This Product

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

Keep Out of Reach of Children

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

Ask A Doctor Before Using If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

Stop Using This Product and Ask A Doctor If

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


Structured Label Content

Uses (USES)

FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

Purpose (PURPOSE)

ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

SHAKE WELL, APPLY SHAMPOO, AND 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%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-723-3929

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

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

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

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


Advanced Ingredient Data


Raw Label Data

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