Otc - Active Ingredient
Tolnaftate 1.0%
Roycederm Tea Tree Body Wash Gel
FDA Label NDC 85424-002
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 Body Wash (NDC 85424-002). 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, warnings, otc - do not use, 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
Indications & Usage
- Helps relieve and prevent athlete's foot(tinea pedis), jock itch (tinea cruris),ringworm(tinea corporis)
- Relieves itching, cracking, scaling, and discomfort caused by these fungal infections
Warnings
For external use only
Otc - Do Not Use
on children under 12 of age except under the advice and supervision of a doctor.
Otc - Ask Doctor
Ask a doctor before use if allergic to anyingredients in this product.
Otc - When Using
avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)
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, rinseand dry skin and feet thoroughly.
- For Athllete'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. This product is not effective on the scalp or nails.
Other Safety Information
Store at 20° to 25°C(68° to 77°F) and out of direct sunlight.
Inactive Ingredient
Purified Water, Artemisia Argyi Leaf, TeaTree Oil, Shea Butter, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit,Lentinula Edodes (Shiitake Mushroom)Extract, Gleditsia Sinensis Fruit, Typhonium Giganteum Whole, Stemona Tuberosa Root, Citric Acid, Amino Acids
Otc - Questions
Email [email protected]
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