Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID d72688ed-d153-4eed-988f-5386eb68559d
Route
TOPICAL
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18 mg)
Inactive Ingredients
Water Alcohol Aminomethylpropanol Polyoxyl 40 Hydrogenated Castor Oil Limonene, (+)- Glycerin Benzyl Salicylate Benzyl Alcohol Linalool, (+/-)- .beta.-citronellol, (r)- Citral Geraniol Artemisia Umbelliformis Flower Coumarin Phenoxyethanol Sodium Benzoate Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Salicylic acid 1.8%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Salicylic acid 1.8%

Use
  • helps eliminate the symptoms of dandruff
Section 51945-4

Warnings

For external use only

Directions
  • apply to affected areas one to 4 times daily or as directed by a doctor 
  • use before going to bed for 4 weeks
  • apply 4 doses on scalp section by section (1 dose = 1 pipette)
  • do not rinse
Active Ingredient

Salicylic acid 1.8%

Inactive Ingredients

water, alcohol denat., aminomethyl propanol, fragrance, PEG-40 hydrogenated castor oil, bifida ferment lysate, limonene, glycerin, benzyl salicylate, benzyl alcohol, linalool, citronellol, citral, geraniol, artemisia umbelliformis flower extract, coumarin, phenoxyethanol, sodium benzoate, citric acid, potassium sorbate

When Using This Product

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use
  • helps eliminate the symptoms of dandruff
Section 51945-4 (51945-4)

Purpose

Antidandruff

Warnings

For external use only

Directions
  • apply to affected areas one to 4 times daily or as directed by a doctor 
  • use before going to bed for 4 weeks
  • apply 4 doses on scalp section by section (1 dose = 1 pipette)
  • do not rinse
Active Ingredient (Active ingredient)

Salicylic acid 1.8%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., aminomethyl propanol, fragrance, PEG-40 hydrogenated castor oil, bifida ferment lysate, limonene, glycerin, benzyl salicylate, benzyl alcohol, linalool, citronellol, citral, geraniol, artemisia umbelliformis flower extract, coumarin, phenoxyethanol, sodium benzoate, citric acid, potassium sorbate

When Using This Product (When using this product)

avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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