ROYCEDERM ANTIFUNGAL .SOAP.- clotrimazole 1% soap

RoyceDerm ANTIFUNGAL .soap. by

Drug Labeling and Warnings

RoyceDerm 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

DOSAGE & ADMINISTRATION

• 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.

WARNINGS

For external use only.

Avoid contact with the eye.

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 & ringworm.

Do not use on children under 2 of age except under the advice and supervision of a doctor.

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

INDICATIONS & USAGE

• Wash affected area well and let product sit 2-3 minutes before rinsing
• Make sure to dry affected area thoroughly.
• Supervise children in the use of this product.
• For Athlete's foot: pay special attention to the spaces between the toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily.
• Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
• This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature 59°-86°F (15°-30°C).

INACTIVE INGREDIENT

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

QUESTIONS

• Visit www.roycederm.com
• Tel:+1(307)461-0958

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ANTIFUNGAL .SOAP. 
clotrimazole 1% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	2.26 g  in 226 g

Inactive Ingredients
Ingredient Name	Strength
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
SODIUM MYRISTATE (UNII: 06BLC4V0IV)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
CERAMIDE NP (UNII: 4370DF050B)
LAURIC ACID (UNII: 1160N9NU9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MYRISTIC ACID (UNII: 0I3V7S25AW)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
MONOSODIUM GLUTARATE (UNII: 36765054OO)
ELAEIS GUINEENSIS (PALM) OIL (UNII: 5QUO05548Z)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-019-01	226 g in 1 CARTON; Type 0: Not a Combination Product	03/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/26/2026

Labeler - RoyceDerm LLC (130329531)