Otc - Active Ingredient
Tolnaftate 1%
Hermon Jock Itch Antifungal Treatment .soap. Bar Soap
FDA Label NDC 85398-031
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 Jock Itch Antifungal Treatment .soap. Bar (NDC 85398-031). 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 - 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
Dosage & Administration
Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as jock itch, athlete's foot, ringworm, and other skin irritations.
Warnings
For external use only.
Otc - When Using
Avoid contact with the eye.
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 - Do Not Use
Do not use on children under 2 years ofage unless directed by 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 beforerinsing.
- Make sure to dry affected area thoroughly.
- Supervise children in theuse of this product.
- For Athlete's foot: pay special attention to the spacesbetween the toes; wear well-fitting, ventilated shoes and change shoes andsocks at least once daily.
- Use 1-2 times daily. Use daily for 4 weeks; if conditionpersists longer, ask a doctor.
- This product is not effective on the scalp or nails.
Other Safety Information
Store at room temperature 59°-86°F (15°-30°C)
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,Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Oil, Fragrance
Otc - Questions
visit us at
www.hermonhealth.com
Tel:573-476-4179
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