Otc - Active Ingredient
Miconazole Nitrate 2%
Roycederm Anti-fungal Cream
FDA Label NDC 85424-021
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 Anti-fungal Cream (NDC 85424-021). 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, dosage & administration, warnings, otc - when using, otc - ask doctor, otc - do not 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
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
Otc - When Using
Avoid contact with the eye.
Otc - Ask Doctor
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.
Otc - Do Not Use
Do not use on children under 2 og age except under the advice and supervision of 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 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.
Otc - Questions
Visit www.roycederm.com
Tel: +1(307)461-0958
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