Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bcffd505-82bd-45ce-9ad0-64a9e63f62b5
Route
TOPICAL
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (18.5 mg)
Inactive Ingredients
Water Glycerin Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Laureth-5 Carboxylic Acid Triethyl Citrate Benzoic Acid Citric Acid Lactic Acid Menthol Niacinamide Peg-55 Propylene Glycol Oleate Peg-60 Hydrogenated Castor Oil Polyquaternium-67 (400 Cps; 2.0-2.2 N%) Propylene Glycol Sodium Benzoate Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Salicylic acid 1.85%

Purpose

Antidandruff


Medication Information

Purpose

Antidandruff

Description

Salicylic acid 1.85%

Uses
  • controls the symptoms of dandruff
  • fights recurrence of the symptoms of dandruff
  • controls scalp itching associated with dandruff
Section 51945-4

Warnings

For external use only

Directions
  • for best results, use at least twice a week or as directed by a doctor
  • shake well
  • wet hair and apply small amount of shampoo
  • massage vigorously
  • leave on for 5 minutes
  • rinse well
Active Ingredient

Salicylic acid 1.85%

Inactive Ingredients

water, glycerin, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, laureth-5 carboxylic acid, triethyl citrate, benzoic acid, citric acid, lactic acid, menthol, niacinamide, PEG-55 propylene glycol oleate, PEG-60 hydrogenated castor oil, polyquaternium-67, propylene glycol, sodium benzoate, sodium chloride, sodium hydroxide, fragrance

Questions Or Comments?

1-888-458-4249

Monday-Friday (9 a.m. - 5 p.m. EST)

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

Uses
  • controls the symptoms of dandruff
  • fights recurrence of the symptoms of dandruff
  • controls scalp itching associated with dandruff
Section 51945-4 (51945-4)

Purpose

Antidandruff

Warnings

For external use only

Directions
  • for best results, use at least twice a week or as directed by a doctor
  • shake well
  • wet hair and apply small amount of shampoo
  • massage vigorously
  • leave on for 5 minutes
  • rinse well
Active Ingredient (Active ingredient)

Salicylic acid 1.85%

Inactive Ingredients (Inactive ingredients)

water, glycerin, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, laureth-5 carboxylic acid, triethyl citrate, benzoic acid, citric acid, lactic acid, menthol, niacinamide, PEG-55 propylene glycol oleate, PEG-60 hydrogenated castor oil, polyquaternium-67, propylene glycol, sodium benzoate, sodium chloride, sodium hydroxide, fragrance

Questions Or Comments? (Questions or comments?)

1-888-458-4249

Monday-Friday (9 a.m. - 5 p.m. EST)

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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