FDA.reportPublic FDA data

82739-019

Manufacturer
Shenzhen Situya Trading Co., Ltd.
Effective date
2024-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:00:21

Label at a glance#

ProductRoyceDerm Tea Tree Oil Antifungal Soap.
Active ingredientCLOTRIMAZOLE
Label structure14 sections

Dosage and administration

Apply to body and feet during shower or bath. Gently massage over the entire body, focusing on areas where odor or skin irritation is a concern. After gently washing, Rinse and dry skin and feet thoroughly.

Storage and handling

■ Store at room temperature and keep away from direct sunlight. ■ Skin discoloration may occur during or after use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Use

INDICATIONS & USAGE SECTION

Relieves and helps prevent recurrence of fungal skin infections including acne, jock itch, athlete's foot, ringworm, and tinea.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ Do not use if you are allergic to any of the ingredients

When Using

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.
If contact occurs, rinse the eyes thoroughly with water.

Stop Use

OTC - STOP USE SECTION

stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are allergic to ingredients in this product

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to body and feet during shower or bath. Gently massage over the entire body, focusing on areas where odor or skin irritation is a concern. After gently washing, Rinse and dry skin and feet thoroughly.

Other information

STORAGE AND HANDLING SECTION

■ Store at room temperature and keep away from direct sunlight.
■ Skin discoloration may occur during or after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Tea Tree Essential Oil, AQUA, Sorbitol, Palm Oil, Coconut Oil Extract, Olive Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate Glutamate, Sodium Hydroxide , Sodium Dodecyl Benzene Sulfonate, Sulfur Spring Extract, Witch Hazel, Ceramide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82739-019ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP. (ANTIFUNGAL SOAP) SOAP [SHENZHEN SITUYA TRADING CO., LTD.]1Unmatched20240621_1b1225df-9c59-41a1-e063-6394a90a860f.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82739-01982739-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PALM OIL5QUO05548ZIACT
OLIVE OIL6UYK2W1W1EIACT
STEARIC ACID4ELV7Z65APIACT
MYRISTIC ACID0I3V7S25AWIACT
TEA TREE OILVIF565UC2GIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
SODIUM MYRISTATE06BLC4V0IVIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
LAURIC ACID1160N9NU9UIACT
SULFUR70FD1KFU70IACT
CERAMIDE 15THT33P7X7IACT
SORBITOL506T60A25RIACT
WITCH HAZEL101I4J0U34IACT

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
3a8407d0-4d32-8d93-e063-6294a90a0be41b1225df-9c59-41a1-e063-6394a90a860f2025-07-22WarningsExact identifier
spl set id: 1b1225df-9c59-41a1-e063-6394a90a860f

Reported adverse events (FAERS/openFDA)#

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