Otc - Active Ingredient
Tolnaftate 1%
Hermon Antifungal Cleansing Bar Soap
FDA Label NDC 85398-033
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 Cleansing Bar (NDC 85398-033). 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 - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, 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.
Warnings
- For external use only.
- When using this product Avoid contact with the eye.
- 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.
- Do not use on children under 2 of age except under the advice and supervision of a doctor.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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.
Storage And Handling
Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Sorbitol, Propylene Glycol, Stearic Acid, Glycerin,Lauric Acid, Sodium Hydroxide, Sodium Laureth Sulfate, Water,Cocamidopropyl Betaine, Sucrose, PEG-8, Trehalose, Menthyl Lactate,PPG-3 Caprylyl Ether, Menthol, Eucalyptus Globulus Leaf Oil, Butyrosper-mum Parkii (Shea) Butter, Sodium Chloride, Charcoal Powder, Niacinamide,Centella Asiatica Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil,Allantoin, Salicylic Acid, Hamamelis Virginiana (Witch Hazel) Water, Diospyros Kaki Fruit Extract, 1,2-Hexanediol, Hydroxyacetophenone, Propylene Glycol Ricinoleate, Ceramide NP, Dimethyl Isosorbide.
Otc - Questions
Tel: +1573 476 4179
Email: [email protected]
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