drug facts

drug facts
SPL v2
SPL
SPL Set ID 926f8c1b-e2bf-4bf4-b93d-02f661e130f7
Route
topical
Published
Effective Date 2011-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium (1 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

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 RE-OCCURENCE.

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.

Inactive Ingredients

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

Description

SELENIUM SULFIDE 1%

Active Ingredient

SELENIUM SULFIDE 1%

Questions/comments?

1-866-690-3030

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.

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 RE-OCCURENCE.

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.

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

Questions/comments? (QUESTIONS/COMMENTS?)

1-866-690-3030

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.

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

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