8b9cd377-aa96-4796-8524-40414ab16c71

SPL v1
SPL
SPL Set ID 8b9cd377-aa96-4796-8524-40414ab16c71
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

Controls flaking, scaling and itching associated with dandruff

Purpose

Anti-Dandruff

Directions
  • Adults and children 12 years and over: wet hair thoroughly, apply shampoo, generously lather, rinse thoroughly. Repeat. Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff.
  • Children under 12 years: ask a doctor

Other Information
  • store between 35o and 85o F (2o and 30oC)
  • protect from freezing
  • see bottom of bottle for lot number and expiration date

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%

Do Not Use
  • On scalp that is broken or inflamed.

  • If you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

When Using This Product

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

If Pregnant Or Breast Feeding

ask a doctor before use

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
Stop Using This Product and Ask Doctor If
  • rash appears
  • condition worsens or does not improve in 2-4 weeks


Structured Label Content

Warnings

For external use only

Uses

Controls flaking, scaling and itching associated with dandruff

Purpose

Anti-Dandruff

Directions
  • Adults and children 12 years and over: wet hair thoroughly, apply shampoo, generously lather, rinse thoroughly. Repeat. Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff.
  • Children under 12 years: ask a doctor

Other Information
  • store between 35o and 85o F (2o and 30oC)
  • protect from freezing
  • see bottom of bottle for lot number and expiration date

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)

Do Not Use
  • On scalp that is broken or inflamed.

  • If you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

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

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a doctor before use

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
Stop Using This Product and Ask Doctor If (Stop using this product and ask doctor if)
  • rash appears
  • condition worsens or does not improve in 2-4 weeks


Advanced Ingredient Data


Raw Label Data

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