drug facts

drug facts
SPL v1
SPL
SPL Set ID de36c704-5e37-4407-8335-2dbe8a38ebf3
Route
topical
Published
Effective Date 2012-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (1 mL)
Inactive Ingredients
water ammonium lauryl sulfate ammonium laureth-3 sulfate dihydrogenated tallow phthalic acid amide coco diethanolamide titanium dioxide dimethicone hypromelloses citric acid monohydrate sodium isostearoyl lactylate dmdm hydantoin aloe vera leaf sodium citrate sodium chloride fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-09-25

Purpose

ANTI-DANDRUFF

Description

SELENIUM SULFIDE 1%


Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

FOR THE 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.

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

WATER (AQUA), AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTALIC ACID AMIDE, COCAMIDE DEA, FRAGRANCE (PARFUM), TITANIUM DIOXIDE, DIMETHICONE, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM ISOSTEAROYL LACTYLATE, DMDM HYDANTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090).

Description

SELENIUM SULFIDE 1%

Section 51945-4

Active Ingredient

SELENIUM SULFIDE 1%

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 Use If You Have

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

FOR THE 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.

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), AMMONIUM LAURYL SULFATE, AMMONIUM LAURETH SULFATE, DIHYDROGENATED TALLOW PHTALIC ACID AMIDE, COCAMIDE DEA, FRAGRANCE (PARFUM), TITANIUM DIOXIDE, DIMETHICONE, HYDROXYPROPYL METHYLCELLULOSE, CITRIC ACID, SODIUM ISOSTEAROYL LACTYLATE, DMDM HYDANTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090).

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

SELENIUM SULFIDE 1%

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 Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)