drug facts

drug facts
SPL v1
SPL
SPL Set ID b5e3550a-de63-42b5-90d3-5c23cca941c6
Route
topical
Published
Effective Date 2016-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
selenium sulfide (10 mg)
Inactive Ingredients
water ammonium laureth-3 sulfate ammonium lauryl sulfate glycol distearate coco monoethanolamide ammonium xylenesulfonate methacrylic acid - methyl methacrylate copolymer (1:1) sodium hydroxide sodium citrate dimethicone cetyl alcohol sodium chloride citric acid monohydrate sodium benzoate stearyl alcohol edetate disodium hypromelloses methylchloroisothiazolinone methylisothiazolinone fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-02-09

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Description

Selenium Sulfide 1%


Medication Information

Warnings

For external use only.

Uses

helps prevent the recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

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 Laureth Sulfate, Ammonium Lauryl Sulfate, Glycol Distearate, Cocamide MEA, Ammonium Xylenesulfonate, Acrylates Copolymer, Sodium Hydroxide, Sodium Citrate, Fragrance (Parfum), Dimethicone, Cetyl Alcohol, Sodium Chloride, Citric Acid, Sodium Benzoate, Stearyl Alcohol, Disodium EDTA, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700).

Description

Selenium Sulfide 1%

Label Copy

Active Ingredient

Selenium Sulfide 1%

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

Warnings

For external use only.

Uses

helps prevent the recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Directions
  • shake well
  • apply shampoo, rinse thoroughly
  • for best results, use at least twice a week or as directed by a doctor
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Glycol Distearate, Cocamide MEA, Ammonium Xylenesulfonate, Acrylates Copolymer, Sodium Hydroxide, Sodium Citrate, Fragrance (Parfum), Dimethicone, Cetyl Alcohol, Sodium Chloride, Citric Acid, Sodium Benzoate, Stearyl Alcohol, Disodium EDTA, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700).

Label Copy

Active Ingredient (Active ingredient)

Selenium Sulfide 1%

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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