ROYCEDERM TINEA ANTIFUNGAL .SOAP.- clotrimazole 1% soap

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Clotrimazole 1%

PURPOSE

Antifungal

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, cracking & discomfort associated with these conditions.

WARNINGS

For external use only.

Avoid contact with the eye.

Stop and aska 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.

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

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

INDICATIONS & USAGE

• Wash the affected area and dry thoroughly.
• Lather and apply to affected area. Leave onfor several minutes before rinsing thoroughly. Use twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For Athlete'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.
• For athlete's foot and ringworm, use daily for4 weeks. For jock itch, use daily for 2 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

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water, LauricAcid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive) Fruit Oil, Sulfur, Fragrance

QUESTIONS

Visit www.roycederm.com

Tel: +1(307)461-0958

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM TINEA ANTIFUNGAL .SOAP. 
clotrimazole 1% soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-022
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
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCROSE (UNII: C151H8M554)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAURIC ACID (UNII: 1160N9NU9U)
GLYCERIN (UNII: PDC6A3C0OX)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
SULFUR (UNII: 70FD1KFU70)
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-022-01	226 g in 1 CARTON; Type 0: Not a Combination Product	04/24/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/24/2026

Labeler - RoyceDerm LLC (130329531)