Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ba7a22d5-0b7c-4c36-abae-800e0ca53f66
Route
TOPICAL
Published
Effective Date 2018-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (10 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Distearyl Phthalamic Acid Sodium Chloride Cocamidopropyl Betaine Sodium Stearoyl Lactylate Dimethicone Citric Acid Monohydrate Sodium Citrate Aloe Vera Leaf Hypromelloses Methylchloroisothiazolinone Methylisothiazolinone Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-27

Description

Selenium Sulfide 1%

Purpose

Anti-dandruff, anti-seborrheic dermatitis


Medication Information

Purpose

Anti-dandruff, anti-seborrheic dermatitis

Description

Selenium Sulfide 1%

Uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Warnings

For external use only.

Directions
  • shake well, wet hair, massage onto scalp and rinse.
  • for best results, use at least twice a week or as directed by a doctor.
Label Copy

Active Ingredient

Selenium Sulfide 1%

Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Distearyl Phthalic Acid Amide, Sodium Chloride, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Stearoyl Lactylate, Fragrance (Parfum), Dimethicone, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090).

Questions Or Comments?

1-877-846-9949

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • for use on color treated or permed hair, rinse thoroughly.
Ask A Doctor Before Use If

you have seborrheic dermatitis in areas other than the scalp.

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.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Structured Label Content

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, anti-seborrheic dermatitis

Warnings

For external use only.

Directions
  • shake well, wet hair, massage onto scalp and rinse.
  • for best results, use at least twice a week or as directed by a doctor.
Label Copy

Active Ingredient (Active ingredient)

Selenium Sulfide 1%

Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium Laureth Sulfate, Distearyl Phthalic Acid Amide, Sodium Chloride, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Stearoyl Lactylate, Fragrance (Parfum), Dimethicone, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090).

Questions Or Comments? (Questions or comments?)

1-877-846-9949

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • for use on color treated or permed hair, rinse thoroughly.
Ask A Doctor Before Use If (Ask a doctor before use if)

you have seborrheic dermatitis in areas other than the scalp.

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.)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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