Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4875f90b-7f40-4f0b-9fcf-048aaef0708f
Route
TOPICAL
Published
Effective Date 2011-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium (1.0000 mL)
Inactive Ingredients
Water Ammonium Lauryl Sulfate Trolamine Lauryl Sulfate Cocamidopropyl Betaine Magnesium Aluminum Silicate Menthol Coco Diethanolamide Dmdm Hydantoin Citric Acid Monohydrate Hypromelloses Fd&c Blue No. 1 D&c Red No. 33 Sodium Citrate Sodium Chloride Ammonium Laureth-2 Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-19

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 RE-OCCURENCE.

Warnings

FOR EXTERNAL USE ONLY.

Directions

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

Questions?

CALL: 1-888-287-1915

Active Ingredient

SELENIUM SULFIDE 1%

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

WATER, AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1, RED 33.

Front and Back Labels

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.

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 RE-OCCURENCE.

Purpose (PURPOSE)

ANTI-DANDRUFF

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

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

Questions? (QUESTIONS?)

CALL: 1-888-287-1915

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1, RED 33.

Front and Back Labels (Front and back labels)

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.

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

All Sections (JSON)