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  5. Label Information: Formula 7 - The Solution

FDA Label for Formula 7 - The Solution

View Indications, Usage & Precautions

Table of Contents

    1. USES:
    2. INDICATION
    3. ACTIVE INGREDIENT
    4. STOP USE AND ASK A DOCTOR IF:
    5. DO NOT USE SECTION
    6. PREGNANCY OR BREAST FEEDING
    7. QUESTIONS OR COMMENTS?
    8. INACTIVE INGREDIENTS
    9. DIRECTIONS:
    10. STORAGE
    11. WARNINGS
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. PRODUCT LABEL

Formula 7 - The Solution 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 


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

solution - solution label


* Please review the disclaimer below.