Otc - Active Ingredient
Tolnaftate 1% (Soap Bar)
Terbinafine Hydrochloride 1% (Cream)
Athlete Foot Treatment Kit
FDA Label NDC 85398-008
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 Athlete Foot Treatment Kit (NDC 85398-008). 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
antifungal
Indications & Usage
Soap Bar
- Helps relieve and prevent itching, burning, cracking, and scaling associated with fungal infections such as athlete's foot, jock itch, ringworm, and other skin irritations.
- Cures most athlete's foot (tinea pedis)
- Cures most jock itch (tinea cruris) and ringworm (tinea corporis)
- Relieves itching, burning, cracking and scaling which accompany these conditions
Cream
Warnings
For external use only
Otc - Do Not Use
- on children under 2 years of age unless directed by a doctor
- on nails and scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor
- If irritatioin occurs or there is no improvement within 2 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Soap Bar
- Wash the affected area thoroughly
- Allow Hermon Antifungal Soap to sit for 1-2 minutes before rinsing.
- Dry the area completely after washing.
- adults and children 12 years and over
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
- for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
- wash hands after each use
- children under 12 years: ask a doctor
Cream
Other Safety Information
Do not use if seal on tube is broken or is not visible. Store at room temperature. Protect from excessive heat (above 104°F / 40°C)
Inactive Ingredient
Soap Bar
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 Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide
Inactive ingredients
Cream
Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexade- cane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum
Otc - Questions
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