ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP.- antifungal soap soap

RoyceDerm Tea Tree Oil Antifungal Soap. by

Drug Labeling and Warnings

RoyceDerm Tea Tree Oil Antifungal Soap. by is a Otc medication manufactured, distributed, or labeled by Shenzhen Situya Trading Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Purpose

Anti-Fungal

Use

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

Warnings

For external use only.

Do not use

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

When Using

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

Stop Use

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

Ask Doctor

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

Keep Oot Of Reach Of Children

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

Directions

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

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

Inactive ingredients

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

Questions

Questions or comments?
Visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP. 
antifungal soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82739-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PALM OIL (UNII: 5QUO05548Z)
OLIVE OIL (UNII: 6UYK2W1W1E)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTIC ACID (UNII: 0I3V7S25AW)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
LAURIC ACID (UNII: 1160N9NU9U)
SULFUR (UNII: 70FD1KFU70)
CERAMIDE 1 (UNII: 5THT33P7X7)
SORBITOL (UNII: 506T60A25R)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82739-019-01	2 in 1 BOX	06/17/2024
1		116 g in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/17/2024

Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Situya Trading Co., Ltd.		706154255	label(82739-019) , manufacture(82739-019)