Psoriasis Scalp Treatment
Approved
Approval ID
14ab77e7-86b0-49d3-8efa-8a80c5a24d74
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 28, 2025
Manufacturers
FDA
Rida LLC
DUNS: 004425803
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Salicylic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83004-026
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 28, 2025
FDA Product Classification
INGREDIENTS (12)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM C14-16 OLEFIN SULFONATEInactive
Code: O9W3D3YF5U
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT
POLYQUATERNIUM-7Inactive
Code: 0L414VCS5Y
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SALICYLIC ACIDActive
Quantity: 3 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/26/2025
Product label
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/26/2025
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.
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 2/28/2025
Active Ingredient
Salicylic Acid 3%
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 5/26/2025
Purpose
Minimizes scalp irritation and itching
WARNINGS SECTION
LOINC: 34071-1Updated: 2/28/2025
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 2/28/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 5/26/2025
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.
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 2/28/2025
Other Information
- Store in a cool, dry place. Protect from direct sunlight.
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 5/26/2025
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