SPL v1
SPL
SPL Set ID 14ab77e7-86b0-49d3-8efa-8a80c5a24d74
Route
TOPICAL
Published
Effective Date 2025-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Polyquaternium-7 Trolamine Panthenol .alpha.-tocopherol Acetate Tea Tree Oil Green Tea Leaf Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Salicylic Acid 3%

Purpose

Minimizes scalp irritation and itching


Medication Information

Purpose

Minimizes scalp irritation and itching

Description

Salicylic Acid 3%

Uses
  • Specifically formulated for the treatment of scalp fungal infections.
  • Effective against ringworm on the scalp.
  • Provides relief from symptoms associated with folliculitis on the scalp.
  • Alleviates discomfort caused by lichen planus affecting the scalp.
Section 50565-1

Warnings
  • For external use only.
  • Do not apply to broken skin or open wounds.
  • Discontinue use if irritation or rash occurs.
  • Keep out of reach of children.
  • If pregnant or breastfeeding, consult a healthcare professional before use.
Directions
  • Shake well before use. 
  • Apply the Folliculitis Scalp Spray to the affected area 2–3 times daily. 
  • Avoid contact with eyes and mucous membranes. 
  • If symptoms persist or worsen, consult a healthcare provider.
Product Label

Active Ingredient

Salicylic Acid 3%

Other Information 
  • Store in a cool, dry place. Protect from direct sunlight.
Inactive Ingredients

Aqua (Water), Trehalose, Benzalkonium Chloride, Mirtazapine, Hexamidine, Sodium Hyaluronate, Salvia Miltiorrhiza Extract, Ginkgo Biloba Extract, Bacillus Subtilis Ferment, Coptis Chinensis Extract, 1,2-Hexanediol, Hydroxypropyl Guar, Saponins, Apple Cider Vinegar


Structured Label Content

Uses
  • Specifically formulated for the treatment of scalp fungal infections.
  • Effective against ringworm on the scalp.
  • Provides relief from symptoms associated with folliculitis on the scalp.
  • Alleviates discomfort caused by lichen planus affecting the scalp.
Section 50565-1 (50565-1)

Purpose

Minimizes scalp irritation and itching

Warnings
  • For external use only.
  • Do not apply to broken skin or open wounds.
  • Discontinue use if irritation or rash occurs.
  • Keep out of reach of children.
  • If pregnant or breastfeeding, consult a healthcare professional before use.
Directions
  • Shake well before use. 
  • Apply the Folliculitis Scalp Spray to the affected area 2–3 times daily. 
  • Avoid contact with eyes and mucous membranes. 
  • If symptoms persist or worsen, consult a healthcare provider.
Product Label (Product label)

Active Ingredient

Salicylic Acid 3%

Other Information 
  • Store in a cool, dry place. Protect from direct sunlight.
Inactive Ingredients (Inactive ingredients)

Aqua (Water), Trehalose, Benzalkonium Chloride, Mirtazapine, Hexamidine, Sodium Hyaluronate, Salvia Miltiorrhiza Extract, Ginkgo Biloba Extract, Bacillus Subtilis Ferment, Coptis Chinensis Extract, 1,2-Hexanediol, Hydroxypropyl Guar, Saponins, Apple Cider Vinegar


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)