Otc - Active Ingredient
Artemisia extract 3%
Salicylic acid 2%
Roycederm Anti Fungal Relief Cream
FDA Label NDC 85424-013
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 Relief Cream (NDC 85424-013). 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, inactive ingredient, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-fungal
Dosage & Administration
Relieves and helps prevent recurrence of fungal infections:itching, flaking, scaling, redness,and irritation.
Inactive Ingredient
Water, Borneol, Sophora Flavescens Root, Cnidium Monnieri Fruit, Kochia Scoparia Pollen, Dictamnus Dasycarpus Root, Smilax Glabra Whole.
Warnings
FOR EXTERNAL USE ONLY
Otc - Ask Doctor
if you are allergic to ingredients in this product.
Otc - When Using
avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.
Otc - Stop Use
condition worsens or does not improve after regular use as directed.
Otc - Keep Out Of Reach Of Children
If swalloWed,get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
- Apply a small amount to the problem areas with circular motions for 3 minutes till the skin absorbs the cream.
- Apply it 2-3 times a day for the best result.
- Continue to use for 3-5 days after symptoms resolve to prevent a recurrence
- Do not use it on pregnant women & children under 12 years of age unless directed by a doctor.
Other Safety Information
Store at room temperature and out of direct sunlight
Otc - Questions
Visit www.roycederm.com
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