FDA.reportPublic FDA data

RoyceDerm Tea Tree Therapeutic

Manufacturer
RoyceDerm LLC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:27:12

Label at a glance#

ProductRoyceDerm Tea Tree Therapeutic
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 3%

OTC - PURPOSE SECTION

Anti-dandruff, anti-psoriasis, anti-seborrheic dermatitis

INDICATIONS & USAGE SECTION

  • Helps control dandruff
  • Relieves itching, scaling, and flaking associated with dandruff

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

  • Do not use it on damaged or inflamed scalp.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

  • If condition worsens or does not improve after regular use.
  • If children under 12 years old, and pregnant or breast-feeding.
  • If swallowed, get medical help or contact a posion control center.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children.

DOSAGE & ADMINISTRATION SECTION

Apply shampoo, massage into the scalp, and leave on hair for 3-5 minutes to allow maximum absorption. Then rinse thoroughly and repeat as needed. For best results, use at least twice a week or as directed by a doctor.

INACTIVE INGREDIENT SECTION

Aqua, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Cocamide MEA, Cocamide Methyl MEA, Sodium Chloride, Glycol Distearate, Acrylates Copolymer, Cetearyl Alcohol, Hydroxyacetophenone, 1,2-Hexanediol, Glycerin, Dipropylene Glycol, Bisamino PEG/PPG-41/3 Aminoethyl PG-Propyl Dimethicone, Guar Hydroxypropyltrimonium Chloride, Piroctone Olamine, Polyquaternium-10, PEG-12 Dimethicone, Citric Acid, Polyquaternium-7, Mentholum, Menthyl Lactate, Mentha Haplocalyx Oil, Disodium EDTA, Sodium Hydroxide, Butylene Glycol, Trehalose, PEG-150 Distearate, Gardenia Jasminoides Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Aloe Barbadensis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

shampooshampoo

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-012-01RoyceDerm Tea Tree Therapeutic350 mL in 1 CARTONGEL3501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01285424-012-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID2968PHW8QPIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
PANTHENOLWV9CM0O67ZIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RoyceDerm Tea Tree TherapeuticSALICYLIC ACID 3%RoyceDerm LLC46542754-2256-a23c-e063-6394a90a77952025-12-19WarningsExact identifier
ndc (package): 85424-012-01
ndc (product): 85424-012
ndc11 (package): 85424001201
spl id: 46542754-2257-a23c-e063-6394a90a7795
spl set id: 46542754-2256-a23c-e063-6394a90a7795

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.