Otc - Active Ingredient
Tolnaftate 1%
Antifungal Boday Wash Soap
FDA Label NDC 85464-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cavtech Holding Llc for the product Antifungal Boday Wash (NDC 85464-001). 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 - when using, otc - stop use, otc - do not use, 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
Antifungal
Indications & Usage
- Helps wash away fungus and bacteria that can cause jock itch, athlete's foot, ringworm, andtinea versicolor
- Aids in relieving itching, irritation, redness, and discomfort associated with fungal infections
- Helps prevent recurrence with regular use
Warnings
For external use only
Otc - When Using
- Avoid contact with eyes. lf contact occurs, rinse thoroughly with water.
- Use only as directed
Otc - Stop Use
- lrritation occurs or worsens
- No improvement is seen after 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch
Otc - Do Not Use
- On broken, irritated, or severely damaged skin
- If allergic to any ingredients
- On children under 2 years of age unless directed by a doctor
Otc - Keep Out Of Reach Of Children
keep out of reach of children
Dosage & Administration
- Use daily in the shower or bath
- Apply to wet skin, lather, and massage gentlyover affected areas
- Leave on skin for 1-2 minutes before rinsing thoroughly
- For bestresults,use consistently as part of your daily hygiene routine
Other Safety Information
- Store at room temperature(15°-30°C/59°-86°F)
- Protect fromexcessive heat and direct sunlight
Inactive Ingredient
Aqua (Water), Sodium Lauroyl Sarcosinate,Cocamidopropy! Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methy! MEA, Disodium Cocoyl Glutamate, Glycerin, Sodium Chloride,Trehalose, Phenoxyetha-nol, Panthenol, Hamamelis Virginiana (Witch Hazel) Water,Aloe Barbadensis Extract, Sodium Benzoate,Mentholum,Arginine, Melaleuca Alterifolia (Tea Tree) Leaf Oil,Mentha Arvensis Extract,Lactobacillus/RiceFerment, Hydrolyzed Oats, Allantoin, Citric Acid, Disodium EDTA, Hydrolyzed Sodium Hyaluronate
Otc - Questions
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