Otc - Active Ingredient
Coltrimazole 1%
Roycederm Tinea Versicolor Relief Soap. Soap
FDA Label NDC 85261-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haikou Pucao Trading Co.,ltd for the product Roycederm Tinea Versicolor Relief Soap. (NDC 85261-311). 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, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-fungal
Indications & Usage
Treats and prevents fungal infections including tinea versicolor, ringworm, athlete's foot, and jock itch.
Otc - Do Not Use
For external use only. Do not use on children under two years of age unless directed by a physician.
Otc - Stop Use
Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.
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
Apply to body and feet during shower or bath. Gently message over the entire body, focusing on affected areas. Rinse thoroughly with water. Use twice daily or as directed by a doctor.
For best results use with RoyceDerm Tinea Treatment Cream.
Other Safety Information
Store at room temperature and out of direct sunlight.
Otc - Questions
Visit www.roycederm.com
Inactive Ingredient
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.
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