FDA Label for Antifungal Medicated Bar
View Indications, Usage & Precautions
Antifungal Medicated Bar Product Label
The following document was submitted to the FDA by the labeler of this product Roycederm 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%
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
Visit at www.roycederm.com
* Please review the disclaimer below.
