Otc - Active Ingredient
Tolnaftate 1%
Antifungal Medicated Bar Soap
FDA Label NDC 85424-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Antifungal Medicated Bar (NDC 85424-001). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop 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
anti-fungal
Indications & Usage
- Cures & prevents most athlete's foot(tinea pedis), jock itch(tinea cruris) & ringworm (tinea corporis).
- Relieves itching, irritation, redness, scaling, and discomfort associated with these conditions.
Warnings
For external use only
Otc - Do Not Use
on children under 2 years of age except under the advice and supervision of a doctor.
Otc - When Using
avoid contact with the eyes. If contact occurs, rinse the eyes thoroughly with water.
Otc - Stop Use
if condition worsens or does not improve after 4 weeks of regular use as directed.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Wash the affected area thoroughly with water.
- Lather the soap and apply it to the affected area.
- Allow the lather to sit on the skin for 2-3 minutes before rinsing thoroughly.
- For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- Use 1-2 times daily for 4 weeks; if the condition persists longer, consult a doctor.
- Supervise children in the use of this product.
Other Safety Information
- Store at room temperature.
- Protect from freezing.
Inactive Ingredient
Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP.
Otc - Questions
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