Otc - Active Ingredient
Tolnaftate 1%
Hermon Antifungal Soap. Soap
FDA Label NDC 85398-019
12 label sections · Submitted to the FDA by Beautivity Llc · 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 85398-019). 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
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product avoide contact with eyesIf 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
lf swallowed, get medical help or contacta Poison Control Center right away.
Inactive Ingredient
Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water, Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Diospyros Kaki Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucurbita Pepo (Pumpkin) Seed Extract, Fragrance
Storage And Handling
Store at room temperature 59°–86°F (15°–30°C).
Otc - Questions
visit us at www.hermonhealth.com
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