drug Facts

 drug Facts
SPL v1
SPL
SPL Set ID 49e3bb4d-7d4d-4cb7-aaf4-e7bad4d7781a
Route
TOPICAL
Published
Effective Date 2013-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (10 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Distearyl Phthalamic Acid Sodium Chloride Cocamidopropyl Betaine Sodium Stearoyl Lactylate Dimethicone Dmdm Hydantoin Citric Acid Monohydrate Sodium Hydroxide Sodium Citrate Aloe Vera Leaf Hypromelloses Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-25

Description

SELENIUM SULFIDE 1%

Purpose

ANTI-DANDRUFF


Medication Information

Purpose

ANTI-DANDRUFF

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 OUT OF HAIR THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

WATER (AQUA), SODIUM LAURETH SULFATE, DISTEARYL PHTHALIC ACID AMIDE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, DIMETHICONE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE (PARFUM), SODIUM HYDROXIDE, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE (CI 77891), BLUE 1 (CI 42090)

Questions Or Comments?

1-888-287-1915

When Using This Product

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

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


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

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

SHAKE WELL, APPLY SHAMPOO AND RINSE OUT OF HAIR 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%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), SODIUM LAURETH SULFATE, DISTEARYL PHTHALIC ACID AMIDE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, SODIUM STEAROYL LACTYLATE, DIMETHICONE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE (PARFUM), SODIUM HYDROXIDE, SODIUM CITRATE, ALOE BARBADENSIS LEAF JUICE, HYDROXYPROPYL METHYLCELLULOSE, TITANIUM DIOXIDE (CI 77891), BLUE 1 (CI 42090)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-287-1915

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE OUT OF HAIR 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)

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


Advanced Ingredient Data


Raw Label Data

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