Formula 3

Formula 3
SPL v3
SPL
SPL Set ID 6068aba9-b0e3-b8f2-e053-2a91aa0a10d5
Route
TOPICAL
Published
Effective Date 2013-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Apricot Kernel Oil Rice Bran Oil Sesame Oil Safflower Oil Jojoba Oil .alpha.-tocopherol Acetate Methylparaben Propylparaben Butylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-10-30

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

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.





Formula 3

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.
Active Ingredient:

Tolnaftate 1%

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.

Keep Out of Reach of Children.

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

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

Representative Labeling










Structured Label Content

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.



Purpose

Antifungal

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.





Formula 3 (FORMULA 3)

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.
Active Ingredient: (Active ingredient:)

Tolnaftate 1%

Inactive Ingredients (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.

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.

Formula 3 Brand Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406 003 15) (FORMULA 3 BRAND Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406-003-15))

Representative Labeling










Advanced Ingredient Data


Raw Label Data

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