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
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
  • 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

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

  • If you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

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)

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

Uses

Controls flaking, scaling and itching associated with dandruff

Purpose

Anti-Dandruff

Warnings

For external use only

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

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

  • If you are allergic to ingredients in this product

Active Ingredient

Selenium Sulfide 1%

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)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:09.268304 · Updated: 2026-03-14T22:52:30.292621