Otc - Active Ingredient
Clotrimazole 1%
Roycederm Antifungal Bar Soap
FDA Label NDC 85424-005
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 Antifungal Bar (NDC 85424-005). 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 - do not use, otc - when using, otc - ask doctor, 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
Anti-fungal
Dosage & Administration
Treats Athlete's foot (tinea pedis), Jock itch(tinea cruris),Ringworm (tinea corporis).-Relieves ltching, burning, cracking.
Warnings
For externaluse only.
Otc - Do Not Use
on children under two years of age unless directed by a doctor.
Otc - When Using
avoid contact withthe eyes.
Otc - Ask Doctor
irritation occurs-there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.
Otc - Keep Out Of Reach Of Children
lf swallowed,call poison control or seek medical help.
Indications & Usage
- Wash affected area well, rinse after 2 minutes. Dry thoroughly.
- Use 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 wellfitting, 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 dailyfor 2 weeks. lf condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
Other Safety Information
store at room temperature and keep away from direct sunlight.
Inactive Ingredient
Sorbitol, Sucrose, Stearic Acid, Tallow, Cocamidopropyl Betaine, Propanediol,Glycerin, Sodium Laureth Sulfate, Water (Aqua), Lauric Acid, Sodium Hydroxide,Sodium Citrate, Charcoal Powder, Volcanic Ash, Melaleuca Alternifolia (Tea Tree)Leaf Oil, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter,Mentha Arvensis Leaf Oil
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