Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 481818ce-f5c5-4c49-9778-c74ca3d5b348
Route
TOPICAL
Published
Effective Date 2015-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Selenium Sulfide (10 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Tea-lauryl Sulfate Cocamidopropyl Betaine Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Citric Acid Monohydrate Ammonium Chloride Dmdm Hydantoin Menthol Sodium Hydroxide Magnesium Aluminum Silicate Hypromelloses Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-11-11

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 reccurence

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 doctor.

Label Copy

Questions?

Call: 1-888-287-1915

Active Ingredient

Selenium Sulfide 1%

Other Information

store at room temperature

Inactive Ingredients

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

When Using This Product
  • avoid contact with eyes
  • if product gets into eyes, rinse thoroughly with water
  • may stain 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

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

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 associated with dandruff and seborrheic dermatitis and to help prevent the chance of reccurence

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 doctor.

Label Copy

Questions?

Call: 1-888-287-1915

Active Ingredient (Active ingredient)

Selenium Sulfide 1%

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, Ammonium Chloride, DMDM Hydantoin, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose, Blue 1 (CI 42090), Red 33 (CI 17200).

When Using This Product (When using this product)
  • avoid contact with eyes
  • if product gets into eyes, rinse thoroughly with water
  • may stain 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)

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

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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