Otc - Active Ingredient
Clotrimazole 1%
Roycederm Tea Tree Oil Antifungal Soap. Soap
FDA Label NDC 85424-004
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 Tea Tree Oil Antifungal Soap. (NDC 85424-004). 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, dosage & administration, other safety information, warnings, 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
Indications & Usage
Relieves and helps prevent recurrence of fungalskin infections including acne, jock itch, athlete'sfoot,ringworm, and tinea.
Dosage & Administration
Apply to body and feet during shower or bath. Gently massage over the entire body, focusing on areas where odor or skin irritation is a concern, After gently washing, Rinse and dry skin and feet thoroughly.
Other Safety Information
Store at room temperature and out of direct sunlight
Warnings
For external use only.
Otc - Ask Doctor
- if you are allergicto ingredients in this product, When using this product avoid contact with eyes. lf contact occurs, rinse the eyes thoroughly with water.
- Stop use and ask a doctor if condition worsens or does not improve after regular use as directed
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.
Inactive Ingredient
Tea Tree Essential Oil,AQUA, Sorbitol, Palm Oil, Coconut Oil Extract,Olive Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate Glutamate, Sodium Hydroxide , Sodium Dodecyl Benzene Sulfonate, Sulfur Spring Extract, Witch Hazel, Ceramide
Otc - Questions
visit www.roycederm.com
* Please review the disclaimer below.
