drug facts

drug facts
SPL v1
SPL
SPL Set ID 11718386-df65-45a5-85c9-b9689d56f0b9
Route
topical
Published
Effective Date 2018-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (10 mg)
Inactive Ingredients
water sodium laureth sulfate triethanolamine lauryl sulfate cocamidopropyl betaine methacrylic acid - methyl methacrylate copolymer (1:1) citric acid monohydrate ammonium chloride menthol sodium hydroxide magnesium aluminum silicate hypromelloses methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-02-15

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

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, Anti-seborrheic dermatitis

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.
Other Information

store at room temperature.

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Description

Selenium Sulfide 1%

Label Copy

Active Ingredient

Selenium Sulfide 1%

Questions Or Comments?

1-866-695-3030

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

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, Anti-seborrheic dermatitis

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.
Other Information (Other information)

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

Active Ingredient (Active ingredient)

Selenium Sulfide 1%

Questions Or Comments? (Questions or comments?)

1-866-695-3030

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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