ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP.- tea tree oil 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 RoyceDerm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Anti-fungal

INDICATIONS & USAGE

• For effective treatment of most athlete's foot(tinea pedis), ringworm (tinea corporis) and jock itch(tinea cruris).
• For effective relief of itching, burning and cracking skin.

DOSAGE & ADMINISTRATION

• Clean the affected area and dry thoroughly.product over the affected area twice daily (morning and night) doctor.
• Supervise children in the use of this product.
• For attention to spaces between the toes; wear well-fitting, ventshoes and socks at least once daily.
• For athlete's foot and rweeks.
• For jock itch, use daily for 2 weeks.
• If condition pdoctor.
• This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

• Store at room temperature
• Avoid excessive heat and direct sunlight.

WARNINGS

For external use only.

on children under 2 years of age unless directed by adoctor.

When using this product

avoid contact withthe eyes.

Stop use and ask a doctor if

irritationoccurs, there is no improvement within 4 weeks forathlete's foot or ringworm, there is no improvementwithin 2 weeks for jock itch.

If swallowed, get medical help or contact aPoison Control Center right away.

INACTIVE INGREDIENT

Sodium Myristoyl Glutamate, Sodium Hydroxide, Sorbitol, Glycerin, Water, Propylene Glycol, Sodium Dodecylbenzenesulfonate, Cocos Nucifera (Coconut) OIl, Elaels Guineensis(Palm) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Olea Europaea (Olive) Fruit Oil,Ceramide NP, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stearic Acid, Lauric Acid, Myristic Acid

QUESTIONS

visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM TEA TREE OIL ANTIFUNGAL SOAP. 
tea tree oil antifungal soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	2.32 g  in 232 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM GLUTAMATE (UNII: W81N5U6R6U)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
AQUA (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
MYRISTIC ACID (UNII: 0I3V7S25AW)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-004-01	232 g in 1 CARTON; Type 0: Not a Combination Product	08/06/2025	02/01/2026
2	NDC: 85424-004-02	232 g in 1 CARTON; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/06/2025

Labeler - RoyceDerm LLC (130329531)

Registrant - RoyceDerm LLC (130329531)