FDA Label for Athlete Foot Medicated Bar
View Indications, Usage & Precautions
Athlete Foot Medicated Bar Product Label
The following document was submitted to the FDA by the labeler of this product Beautivity Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Tolnaftate 1% (Soap Bar)
Terbinafine Hydrochloride 1% (Cream)
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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