FDA Label for Formula 7 Thegel
View Indications, Usage & Precautions
Formula 7 Thegel Product Label
The following document was submitted to the FDA by the labeler of this product The Tetra Corporation. 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.
Uses:
Antifungal
Indications & Usage
For effective treatment of most athlete’s foot and ringworm.
Relieves:
• Itching
• Scaling
• Cracking
• Redness
• Soreness
• Burning
• Irritation
Prevents the recurrence of most athlete’s foot (dermatophytosis) with daily use.
Active Ingredient
Tolnaftate 1%
Stop Use And Ask A Doctor If:
• When using for treatment of athlete’s foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
• When using for the prevention of athlete’s foot: If irritation occurs, discontinue use and consult a doctor.
Do Not Use Section
Do not use on children under 2 years of age unless directed by a doctor.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
Questions Or Comments?
1-800-826-0479
9:00 AM to 5:30 PM EST.
Inactive Ingredients
Inactive Ingredients: Water (aqua),C12-15 Alkyl Benzoate, SimmondsiaChinensis (Jojoba) Oil, Glycerin,Oleth-10, Oleth-5, Oleth-3 Phosphate,PEG-20 Hydrogenated Lanolin,Butylene Glycol, Urea, Ethoxydiglycol,N-Acetyl-L-Cysteine, TocopherolAcetate (Vitamin E), Melaleuca
Alternifolia (Tea Tree) Oil, DisodiumEDTA, Ethylhexylglycerin, CaprylylGlycol, Phenoxyethanol, Aminomethylpropanediol,Sodium Chloride.
Directions:
For treatment of athlete’s foot and ringworm:
• Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) 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. This product is not effective on the scalp or nails.
To prevent athlete’s foot:
• Wash the feet and dry thoroughly.
• Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
• Supervise children in the use of this product.
• Pay special attention to spaces between the toes; wear well-fitting,ventilated shoes, and change shoes and socks at least once daily.
Other Information
Store at room temperature, 25°C (77°F).
Warnings
For external use only.
When using this product avoid contact with eyes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Product Label
* Please review the disclaimer below.
