Otc - Active Ingredient
Miconazole Nitrate 2%
Roycederm Tinea Antifungal Cream
FDA Label NDC 85424-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Tinea Antifungal Cream (NDC 85424-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & 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.
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
Avoid contact with the eyes.
Otc - Stop Use
If irritation occurs or if there is no improvement within 4 weeks, discountine use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & 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.
Other Safety Information
Store at room temperature and out of direct sunlight.
Inactive Ingredient
WATER, ARTEMISIA EXTRACT IFHFI], SOPHORA FLAVESCENS ROOT. CNIDIUM MONNIERI FRUITKOCHIA SCOPARIA POLLEN
DICTAMNUS DASYCARPUSROOT, SMILAX GLABRA WHOLE
Otc - Questions
Visit www.roycederm.com or email [email protected]
Package Label.Principal Display Panel
Antifungal Cream Label (Label)
* Please review the disclaimer below.
