SPL v1
SPL
SPL Set ID 0fcbd163-bb8d-4f09-a595-192c56222354
Route
TOPICAL
Published
Effective Date 2010-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium (1 mL)
Inactive Ingredients
Water Ammonium Lauryl Sulfate Ammonium Laureth-2 Sulfate Coco Diethanolamide Titanium Dioxide Dimethicone Hypromellose 2208 (100 Mpa.s) 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 2010-10-15

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

Active Ingredient

Selenium Sulfide 1%

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic 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)

When Using This Product

avoid contact with eyes. If contact occurs, rinse 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

Package Front and Back Labels
ra11.jpg
Ask A Doctor Before Using If You Have

Seborrheic dermatitis in areas other than the scalp

Stop Using This Product and Ask Doctor If

condition worsens or does not improve after regular use of this product as directed


Structured Label Content

Uses

For relief of flaking, and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of re-occurence

Purpose

Anti-Dandruff

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

Active Ingredient

Selenium Sulfide 1%

Other Information (Other information)

Store at room temperature

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic 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)

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse 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

Package Front and Back Labels
ra11.jpg
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 Doctor If (Stop using this product and ask 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)