Otc - Active Ingredient
Miconazole Nitrate 2%
Clotrimazole 1%
Roycederm Tinea Antifungal .soap. Soap
FDA Label NDC 85424-022
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 .soap. (NDC 85424-022). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, 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 jock itch (tinea cruris).
- For effective relief of itching,burning, cracking and discomfort associated with these conditions.
Warnings
- For external use only
- When using this product, avoid contact with the eye.
- Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
- Do not use on children under 2 of age except under the advice and supervision of a doctro.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poision Control Center right away.
Indications & Usage
- Wash the affected area and dry thoroughly.
- Apply a thin layer of the productover 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 the 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 persistslonger, ask 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
Cream:
Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium MonnieriFruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract,Smilax Glabra Root Extract
Soap:
Sorbitol, Sucrose, Stearic Acid, Propanediol, Sodium Lauroamphoacetate, Water,Lauric Acid, Glycerin, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter,Aloe Barbadensis Leaf Extract, Potassium Cocoyl Glycinate, Olea Europaea (Olive)Fruit Oil, Sulfur, Fragrance
Otc - Questions
Visit: www.roycederm.com
Tel: +1 (307) 461 0958
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