f5b5fee6-2822-4333-8c0d-b96f5d386e18

SPL v1
SPL
SPL Set ID f5b5fee6-2822-4333-8c0d-b96f5d386e18
Route
topical
Published
Effective Date 2010-10-15
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 2010-10-15

Purpose

Anti-Dandruff

Description

Selenium Sulfide 1%


Medication Information

Warnings

For external use only

Uses

For relief of flaking, and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of re-occurence

Purpose

Anti-Dandruff

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

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)

Description

Selenium Sulfide 1%

Active Ingredient

Selenium Sulfide 1%

Questions? Comments?

1 - 877 - 932 - 7948

When Using This Product

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

Keep Out of Reach of Children

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

Package Front and Back Labels
ra11.jpg
Ask A Doctor Before Using If You Have

Seborrheic dermatitis in areas other than the scalp

Stop Using This Product and Ask Doctor If

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


Structured Label Content

Warnings

For external use only

Uses

For relief of flaking, and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of re-occurence

Purpose

Anti-Dandruff

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

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)

Active Ingredient

Selenium Sulfide 1%

Questions? Comments?

1 - 877 - 932 - 7948

When Using This Product (When using this product)

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

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

Package Front and Back Labels
ra11.jpg
Ask A Doctor Before Using If You Have (Ask a doctor before using if you have)

Seborrheic dermatitis in areas other than the scalp

Stop Using This Product and Ask Doctor If (Stop using this product and ask 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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