FDA.reportPublic FDA data

RoyceDerm Tea Tree Body Wash

Manufacturer
RoyceDerm LLC
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:17:06

Label at a glance#

ProductRoyceDerm Tea Tree Body Wash
Active ingredientTOLNAFTATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1.0%

OTC - PURPOSE SECTION

Anti-Fungal

INDICATIONS & USAGE SECTION

  • Helps relieve and prevent athlete's foot(tinea pedis), jock itch (tinea cruris),ringworm(tinea corporis)
  • Relieves itching, cracking, scaling, and discomfort caused by these fungal infections

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on children under 12 of age except under the advice and supervision of a doctor.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if allergic to anyingredients in this product.

OTC - WHEN USING SECTION

avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

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, rinseand dry skin and feet thoroughly.
  • For Athllete's foot: pay special attention to the spaces between the toes; wear well-fitting,ventilated shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at 20° to 25°C(68° to 77°F) and out of direct sunlight.

INACTIVE INGREDIENT SECTION

Purified Water, Artemisia Argyi Leaf, TeaTree Oil, Shea Butter, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit,Lentinula Edodes (Shiitake Mushroom)Extract, Gleditsia Sinensis Fruit, Typhonium Giganteum Whole, Stemona Tuberosa Root, Citric Acid, Amino Acids

OTC - QUESTIONS SECTION

Email service@roycederm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

body wash packagebody wash package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2689792tolnaftate 1 % Medicated Liquid SoapPSN2
2689792tolnaftate 10 MG/ML Medicated Liquid SoapSCD2
2689792tolnaftate 1 % Medicated Liquid SoapSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860009297029GTIN-13: 0860009297029
EAN-13: 0860009297029
GTIN-12: 860009297029
UPC-A: 860009297029
GTIN storage (14 digits): 00860009297029		body wash.jpg
QR code linkQR Codeqrco.de/bfnjYTbody wash.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-002-01RoyceDerm Tea Tree Body Wash500 g in 1 BOTTLEGEL5002

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00285424-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLEDITSIA SINENSIS FRUITA6W0J6UO7QIACT
CITRIC ACID2968PHW8QPIACT
AMINO ACIDS0O72R8RF8AIACT
LENTINULA EDODES MYCELIUMCU2S39TB8OIACT
WATER059QF0KO0RIACT
CNIDIUM MONNIERI FRUITV1IA3S3CUSIACT
ARTEMISIA ARGYI LEAF2JYC99Q0WZIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
SAUROMATUM GIGANTEUM WHOLEC61Y66MY4HIACT
SHEA BUTTERK49155WL9YIACT
TEA TREE OILVIF565UC2GIACT
TOLNAFTATE06KB629TKVACTIB
STEMONA TUBEROSA ROOT7S9328671ZIACT

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
43f8c506-2110-de1b-e063-6294a90afba23a2bb86e-36a2-2cd7-e063-6394a90a3fb42025-11-19WarningsExact identifier
spl id: 43f8c506-2110-de1b-e063-6294a90afba2
spl set id: 3a2bb86e-36a2-2cd7-e063-6394a90a3fb4

Reported adverse events (FAERS/openFDA)#

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