FDA Label for Tm-tolnaftate Lr
View Indications, Usage & Precautions
Tm-tolnaftate Lr Product Label
The following document was submitted to the FDA by the labeler of this product Singular Dreamer Ltd.dba True Marker. 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.
Active Ingredient
Tolnaftate 1%
Purpose
Antifungal
Uses
- for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
- for the prevention of most Athlete's foot with daily use eliminates fungus on fingers, toes and around the nails.
- eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.
Warnings
• For external use only
•
Do Not Use– On children under 2 years of age
•
When using this product, do not get into eyes
•
Stop use and ask a doctor
- for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
- for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor
- for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
- for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles and skin around the nails or as directed by a doctor
- supervise children in the use of this product
- 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 for athlete's foot and ringworm, use daily for 4 weeks
- if condition persists longer, consult a doctor.
Other Information
- Store at 15 - 30°C (59 - 86°F)
- avoid excessive heat
- do not use if package is damaged
Inactive Ingredients
a-Bisabalol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Curcuma Longa (Turmeric) Extract, Dimethyl Isosorbide, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethyl Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate
60, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Zingiber Officinalis (Ginger) Extract.
Product Label
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