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  5. Label Information: Formula 3

FDA Label for Formula 3

View Indications, Usage & Precautions

Table of Contents

    1. FORMULA 3
    2. ACTIVE INGREDIENT:
    3. PURPOSE
    4. USES:
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. FORMULA 3 BRAND ANTIFUNGAL TOLNAFTATE 1% ANTIFUNGAL SOLUTION 15ML (49406-003-15)

Formula 3 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.

Formula 3




Active Ingredient:



Tolnaftate 1%


Purpose



Antifungal


Uses:



For effective treatment of most athlete's foot and ringworm.

Relieves:

  • Itching
  • Soreness
  • Scaling
  • Burning
  • Cracking
  • Irritation
  • Redness

    • Prevents the recurrence of most athlete's foot (dermatophytosis) 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 if

  • When using for 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.

    • If pregnant or breastfeeding ask a health professional before use.




Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



For treatment of athlete's foot and ringworm

  • Clean the affected area and dry thoroughly. Apply a thin layer of the product over 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 scalp or nail.

    • To prevent athlete's foot:

    • Clean 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.

Inactive Ingredients



Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, Jojoba Oil, Vitamin E Acetate, Methyl Paraben, Propyl Paraben and Butyl Paraben.


Formula 3 Brand Antifungal Tolnaftate 1% Antifungal Solution 15Ml (49406-003-15)



Representative Labeling

outer label - formula3outer

outer label - formula3outer





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