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Formula 3

The Tetra Corporation
Elba Laboratories

FORMULA 3


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Formula 3
Formula 3
Formula 3

Formula 3

TOLNAFTATE SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49406-003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 10 mg

Inactive Ingredients

Ingredient Name Strength
Apricot Kernel Oil
RICE BRAN OIL
SESAME OIL
SAFFLOWER OIL
Jojoba Oil
.ALPHA.-TOCOPHEROL ACETATE
METHYLPARABEN
PROPYLPARABEN
BUTYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49406-003-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-10-30


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