SPL v5
SPL
SPL Set ID ca52af37-c3a2-414c-a24a-a37a92925133
Route
TOPICAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Ceteth-20 Chlorocresol Mineral Oil Petrolatum Sodium Phosphate, Monobasic, Anhydrous Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-10-07

Description

Drug Facts

Purpose

Antifungal Cream


Medication Information

Purpose

Antifungal Cream

Description

Drug Facts

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Section 42229-5

Drug Facts

Section 50565-1

Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Warnings
  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).
Directions
  • 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 the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

1-800-222-1087

Active Ingredient

Tolnaftate USP 1%

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.
Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Principal Display Panel – 1.25 Oz Tube

Dr. Sheffield's NDC 11527-051-40

1% Tolnafate

Antifungal Cream

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM

Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 Oz Carton

Dr. Sheffield's NDC 11527-051-40

1%  Tolnafate

Antifungal Cream 

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM 

Net Wt. 1.25 OZ (35.4 g)


Structured Label Content

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Purpose

Antifungal Cream

Warnings
  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).
Directions
  • 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 the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
Questions?

1-800-222-1087

Active Ingredient (Active ingredient)

Tolnaftate USP 1%

Other Information (Other information)
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.
Inactive Ingredients (Inactive ingredients)

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Principal Display Panel – 1.25 Oz Tube (Principal Display Panel – 1.25 oz Tube)

Dr. Sheffield's NDC 11527-051-40

1% Tolnafate

Antifungal Cream

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM

Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 Oz Carton (Principal Display Panel – 1.25 oz Carton)

Dr. Sheffield's NDC 11527-051-40

1%  Tolnafate

Antifungal Cream 

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM 

Net Wt. 1.25 OZ (35.4 g)


Advanced Ingredient Data


Raw Label Data

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