Otc - Active Ingredient
Tolnaftate 1%
Hermon Antifungal .soap. Soap
FDA Label NDC 85398-025
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 .soap. (NDC 85398-025). 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, indications & usage, warnings, otc - do not use, 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
Antifungal
Dosage & Administration
- For effective treatment of most athlete’s foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
- For effective relief of itching, burning and cracking skin.
Indications & Usage
- Wash affected area well and let product sit 2–3 minutes before rinsing.
- Make sure to dry affected area thoroughly.
- Supervise children in the use of this product.
- For Athlete’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.
- Use 1–2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
- This product is not effective on the scalp or nails.
Warnings
For external use only.
Otc - Do Not Use
on children under 2 years of age unless directed bya doctor.
Otc - When Using
avoide contact with eyes, If contact occurs, rinse 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 - Keep Out Of Reach Of Children
If swallowed,get medical helpor contact a Poison Control Center right away.
Inactive Ingredient
Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water (Aqua), Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Oil, Fragrance
Other Safety Information
Store at room temperature 59°–86°F (15°–30°C).
Otc - Questions
visit us at www.hermonhealth.com
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