ROYCEDERM TEA TREE BODY WASH- tea tree body wash gel

RoyceDerm Tea Tree Body Wash by

Drug Labeling and Warnings

RoyceDerm Tea Tree Body Wash by is a Otc medication manufactured, distributed, or labeled by RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1.0%

PURPOSE

Anti-Fungal

INDICATIONS & USAGE

• 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

For external use only

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

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

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

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.

ask a health professional before use

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

DOSAGE & 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, 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

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

QUESTIONS

Email service@roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM TEA TREE BODY WASH 
tea tree body wash gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q)
CITRIC ACID (UNII: 2968PHW8QP)
AMINO ACIDS (UNII: 0O72R8RF8A)
LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O)
WATER (UNII: 059QF0KO0R)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
SAUROMATUM GIGANTEUM WHOLE (UNII: C61Y66MY4H)
SHEA BUTTER (UNII: K49155WL9Y)
TEA TREE OIL (UNII: VIF565UC2G)
STEMONA TUBEROSA ROOT (UNII: 7S9328671Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-002-01	500 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/01/2025

Labeler - RoyceDerm LLC (130329531)

Registrant - RoyceDerm LLC (130329531)