Otc - Active Ingredient
- Soap Bar: Tolnaftate 1%
- Cream: Tolnaftate 1%
Hermon Athletes Foot Tolnaftate 1% Kit
FDA Label NDC 85398-018
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 Athletes Foot Tolnaftate 1% Kit (NDC 85398-018). 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 - do not use, otc - when using, otc - ask doctor, 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
- cures most athlete's foot (tinea pedis)
- cures most jock itch(tinea cruris) and ringworm (tinea corporis)
- relieves itching, burning, cracking and scaling which accomppany these conditions
- For effective relief of itching, cirritation, redness, scaling, cracking, burning, soreness, anddiscomfort which can accompany these conditions.
Warnings
For external use only
Otc - Do Not Use
- on children under 2 years of age unless directed by a doctor.
- On nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Ask Doctor
if irritation occurs or there is no improvement within 2 wveeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions (Cream)
- adults and children 12 years and over
- use the tip of thecap to break the seal and open the tube
- wash the affedted 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 ttoes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
- on the bottom or sides ofthe foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
- for jock itch and ringworm: apply oncea 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
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- use daily for2 weeks
- Wet skin with warm water and lather soap.
- Gently massage onto affeected areas.
- Rinse thoroughly and dry.
- Use twice daily or as directed by a doctor.
Directions (Soap Bar)
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
Cream:
Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyc Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurrate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice
Soap Bar:
Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aqua (Water), Sorlbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glyceerin, Stearic Acid, Lauric Acid, Myristic Acid, Šodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide
Otc - Questions
visit us at www.hermonhealth.com
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