SPL v2
SPL
SPL Set ID 7498ba49-9ec8-4057-845b-94e2320870b2
Route
TOPICAL
Published
Effective Date 2011-08-19
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 Hypromelloses Citric Acid Monohydrate Sodium Isostearoyl Lactylate Dmdm Hydantoin Aloe Vera Leaf Sodium Citrate Sodium Chloride Fd&c Blue No. 1 Dihydrogenated Tallow Phthalic Acid Amide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-19

Description

Selenium Sulfide 1%

Purpose

Anti-Dandruff


Medication Information

Purpose

Anti-Dandruff

Description

Selenium Sulfide 1%

Uses

Controls flaking, scaling and itching associated with 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

Do Not Use
  • on scalp that is broken or inflamed

  • if you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

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)

Questions? Comments?

1 - 877 - 932 - 7948

Front and Back Labels

When Using This Product

avoid contact with eyes. If product gets into eyes, rinse eyes thoroughly with water.

Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If

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


Structured Label Content

Uses

Controls flaking, scaling and itching associated with dandruff.

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

Do Not Use (Do not use)
  • on scalp that is broken or inflamed

  • if you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

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)

Questions? Comments?

1 - 877 - 932 - 7948

Front and Back Labels

When Using This Product (When using this product)

avoid contact with eyes. If product gets into eyes, rinse eyes thoroughly with water.

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.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

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


Advanced Ingredient Data


Raw Label Data

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