Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 63101d76-aea7-405c-9c36-f287ddb3f143
Route
TOPICAL
Published
Effective Date 2012-03-22
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 2012-03-20

Description

Selenium Sulfide 1%

Purpose

Anti-Dandruff


Medication Information

Purpose

Anti-Dandruff

Description

Selenium Sulfide 1%

Uses

For relief of flaking and itching due to dandruff, for seborrheic dermatitis, and to help prevent their recurrence.

Warnings

For external use only

Directions
  • Shake well. Shampoo, then rinse thoroughly.
  • For best results, use at least twice a week or as directed by a doctor.

Label Copy

Active Ingredient

Selenium Sulfide 1%

Questions/comments?

1 - 866 - 695 - 3030

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 the eyes. If contact occurs, rinse eyes thoroughly with water. For use on color-treated or permed hair, rinse thoroughly.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Using If You Have

seborrheic dermatitis in areas other than the scalp.


Structured Label Content

Uses

For relief of flaking and itching due to dandruff, for seborrheic dermatitis, and to help prevent their recurrence.

Purpose

Anti-Dandruff

Warnings

For external use only

Directions
  • Shake well. Shampoo, then rinse thoroughly.
  • For best results, use at least twice a week or as directed by a doctor.

Label Copy (Label copy)

Active Ingredient

Selenium Sulfide 1%

Questions/comments? (Questions/Comments?)

1 - 866 - 695 - 3030

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 the eyes. If contact occurs, rinse eyes thoroughly with water. For use on color-treated or permed hair, rinse thoroughly.

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)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Using If You Have (Ask a doctor before using if you have)

seborrheic dermatitis in areas other than the scalp.


Advanced Ingredient Data


Raw Label Data

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