ROYCEDERM TINEA ANTIFUNGAL .CREAM. AND .SOAP.- cream and soap kit

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

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 and discomfort associated with these conditions.

WARNINGS

• For external use only
• When using this product, 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 and ringworm.
• Do not use on children under 2 of age except under the advice and supervision of a doctro.

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

INDICATIONS & USAGE

• Wash the affected area and dry thoroughly.
• Apply a thin layer of the productover affected area 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 for 4 weeks;
• For jock itch, use daily for 2 weeks.
• If condition persistslonger, ask a doctor.
• This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight.

INACTIVE INGREDIENT

Cream:

Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium MonnieriFruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract,Smilax Glabra Root Extract

Soap:

Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water,Lauric Acid, 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 .CREAM. AND .SOAP. 
cream and soap kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-023

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-023-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	05/04/2026

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 CARTON	2 g  in 226
Part 2	0 TUBE	1 g  in 57

Part 1 of 2

ROYCEDERM TINEA ANTIFUNGAL .SOAP. 
clotrimazole 1% soap

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/04/2026

Part 2 of 2

ROYCEDERM TINEA ANTIFUNGAL CREAM 
miconazole nitrate 2% cream

Product Information
Item Code (Source)	NDC: 85424-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)
BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
WATER (UNII: 059QF0KO0R)
CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
WORMWOOD (UNII: F84709P2XV)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-011-01	57 g in 1 TUBE; 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	05/04/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/04/2026

Labeler - RoyceDerm LLC (130329531)