Initial Drug Listing - Roycederm Tinea Antifungal Cream
40089a7d-c893-4e90-e063-6294a90aa6f9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Miconazole Nitrate 2%
Medication Information
Warnings and Precautions
For external use only
Indications and Usage
- For effective treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm).
- For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with the conditions.
Dosage and Administration
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over 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 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 persists longer, consult a doctor.
This product is not effective on the scalp or nails.
Description
Miconazole Nitrate 2%
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9
If irritation occurs or if there is no improvement within 4 weeks, discountine use and consult a doctor.
Section 50567-7
Avoid contact with the eyes.
Section 50570-1
Do not use on children under 2 years of age unless directed by a doctor.
Section 51727-6
WATER, ARTEMISIA EXTRACT IFHFI], SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE
Section 51945-4
Section 53413-1
Visit www.roycederm.com or email [email protected]
Section 55105-1
Antifungal
Section 55106-9
Miconazole Nitrate 2%
Section 60561-8
Store at room temperature and out of direct sunlight.
Structured Label Content
Indications and Usage (34067-9)
- For effective treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm).
- For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with the conditions.
Dosage and Administration (34068-7)
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over 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 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 persists longer, consult a doctor.
This product is not effective on the scalp or nails.
Warnings and Precautions (34071-1)
For external use only
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9 (50566-9)
If irritation occurs or if there is no improvement within 4 weeks, discountine use and consult a doctor.
Section 50567-7 (50567-7)
Avoid contact with the eyes.
Section 50570-1 (50570-1)
Do not use on children under 2 years of age unless directed by a doctor.
Section 51727-6 (51727-6)
WATER, ARTEMISIA EXTRACT IFHFI], SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Visit www.roycederm.com or email [email protected]
Section 55105-1 (55105-1)
Antifungal
Section 55106-9 (55106-9)
Miconazole Nitrate 2%
Section 60561-8 (60561-8)
Store at room temperature and out of direct sunlight.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:37.621356 · Updated: 2026-03-14T23:12:56.390264