Uses:
Antifungal
Formula 7 - The Solution
FDA Label NDC 49406-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Tetra Corporation for the product Formula 7 - The Solution (NDC 49406-007). 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 uses:, indication, active ingredient, stop use and ask a doctor if:, do not use section, pregnancy or breast feeding, questions or comments?, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indication
For effective treatment of most athlete’s foot
(tinea pedis) and ringworm (tinea corporis).
Relieves:
• Itching
• Scaling
• Cracking
• Redness
• Soreness
• Burning
• Irritation
Prevents the recurrence of most athlete’s foot 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 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 unles as 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 ring worm.
• 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 (morningand/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
Storage
Store above 12°C (55°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
Solution (Solution Label)
* Please review the disclaimer below.
