FDA Label for Tolnafi-al
View Indications, Usage & Precautions
Tolnafi-al Product Label
The following document was submitted to the FDA by the labeler of this product True Marker Pharmaceuticals, Inc.. 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 (S)
Tolnaftate 1%
Purpose
Antifungal
Uses
• Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
• For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
• Prevents most tinea pedis (athlete’s foot) with daily use.
Warnings
• For external use only
•
Do Not Use– On children under 2 years of age unless directed by a doctor.
•
When using this product, avoid contact with 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
Inactive Ingredients
If swallwed, get medical help or contact a Poison Control Center right away
Helianthus annuus flowering top, Vitis Vinifera Fruit Oil, Peppermint, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene.
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
Product Label
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