Formula 3 Solution
FDA Label NDC 49406-003

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 3 (NDC 49406-003). 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 formula 3, active ingredient:, purpose, uses:, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)


Outer Inner Label (Formula3boxinner)

Outer Inner Label (Formula3boxinner)


Inner Label (Formula3inner)

Inner Label (Formula3inner)


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