drug facts

drug facts
SPL v1
SPL
SPL Set ID cb82bdc9-4505-4f07-934c-030ee371d5aa
Route
topical
Published
Effective Date 2012-06-05
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 ammonium laureth-2 sulfate cocamidopropyl betaine magnesium aluminum silicate menthol coco diethanolamide dmdm hydantoin citric acid monohydrate hypromellose 2208 (100 mpa.s) sodium citrate sodium chloride d&c blue no. 4 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-06-04

Purpose

ANTI-DANDRUFF

Description

SELENIUM SULFIDE 1%


Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

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

Purpose

ANTI-DANDRUFF

Directions

SHAKE WELL, APPLY SHAMPOO, AND 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 (PARFUM), MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200).

Description

SELENIUM SULFIDE 1%

Label Copy

Active Ingredient

SELENIUM SULFIDE 1%

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 O DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

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

Directions (DIRECTIONS)

SHAKE WELL, APPLY SHAMPOO, AND 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 (PARFUM), MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200).

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

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 O DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.


Advanced Ingredient Data


Raw Label Data

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