Otc - Active Ingredient
Tolnaftate 1%
Hermon Antifungal Jock Itch Body Wash Gel
FDA Label NDC 85398-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Hermon Antifungal Jock Itch Body Wash (NDC 85398-016). 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 - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Dosage & Administration
- Treats most jock itch, athlete's foot, and ringworm
- Relieves itching, burning, cracking,and discomfort associated with fungal infections
- Helps prevent recurrence of jock itch and athlete's foot with daily use
Warnings
For external use only
Otc - When Using
- Avoid contact with eyes. lf contact occurs, rinse thoroughly with water
- Do not use onbroken or severely irritated skin
- Do not apply over large areas of the body
Otc - Ask Doctor
- lrritation occurs
- No improvement is seen within 2 weeks (for jock itch and ringworm)
- No improvement is seen within 4 weeks (for athlete's foot)
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact aPoison Control Center right away.
Indications & Usage
- Use daily in the shower or bath
- Apply to affected area and surrounding skin
- Lather and leave on skin for 1-2 minutes, thenrinse thoroughly
- Dry affected area completely
- For jock itch and ringworm, use twice daily for 2 weeks
- For athlete's foot, use twice daily for 4 weeks
- To help prevent recurrence, continue use after symptoms disappear or as directed by a doctor
Other Safety Information
Store at 15°-30°C(59°-86°F)
Do not use if seal under cap is broken or missing
Inactive Ingredient
Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methyl MEA,Disodium Cocoyl Glutamate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride,Trehalose, Phenoxyethanol, Panthenol, Hamamelis virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Extract, Sodium Benzoate,Menthol, Arginine, Mentha Arvensis Leaf Extract, Lactobacillus/Rice Ferment, Hydrolyzed OatProtein, Allantoin, Citric Acid, Disodium EDTA,Hydrolyzed Sodium Hyaluronate.
Otc - Questions
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