ROYCEDERM ANTI-FUNGAL CREAM- miconazole nitrate 2% cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Miconazole Nitrate 2%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

• For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jockitch(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 doct 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 og age except under the advice and supervision of a doctor.

Keep out of reach of children 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 useof this product.
• For Athlete's foot: pay special attention to the spacesbetween the toes; wear well-fitting, ventilated shoes and change shoes andsocks at least once daily. Use 1-2 times daily.
• Use daily for 4 weeks; ifcondition persists longer, ask a doctor.
• This product is not effective onthe scalp or nails

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROYCEDERM ANTI-FUNGAL CREAM 
miconazole nitrate 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85424-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)
CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)
DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)
SMILAX GLABRA TUBER (UNII: PES3YXA3LR)
WORMWOOD (UNII: F84709P2XV)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85424-021-01	100 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)