SPL v1
SPL
SPL Set ID dc90e4a2-9b63-4dfa-a35b-3789ebb336d4
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 g)
Inactive Ingredients
Water Trehalose Benzalkonium Chloride Mirtazapine Hexamidine Sodium Hyaluronate Ginkgo 1,2-hexanediol Apple Cider Vinegar Bacillus Subtilis Coptis Japonica Whole Hydroxypropyl Guar Hydroxypropyltrimonium Chloride Salvia Miltiorrhiza Root Quillaja Saponaria Saponins Fraction C

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER 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 folliculitis.
  • Provides relief from symptoms associated with folliculitis on the scalp.
  • Helps reduce redness, itching, and discomfort caused by inflamed hair follicles on 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 folliculitis.
  • Provides relief from symptoms associated with folliculitis on the scalp.
  • Helps reduce redness, itching, and discomfort caused by inflamed hair follicles on 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)