SPL v4
SPL
SPL Set ID 63665de7-8415-651f-e053-2991aa0ac2bb
Route
TOPICAL
Published
Effective Date 2018-01-22
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 2010-02-11

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps keep it from coming back
Section 42229-5

Drug Facts

Section 50567-7

When using this product avoid contact with eyes

Warnings

For external use only

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

  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • pay special attention to the spaces between the toes
  • wear well fitting ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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.

Do Not Use
  • on children under 2 years of age unless directed by a doctor
Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Active Ingredient

Tolnaftate USP 1%

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • Lot No. and Exp date: see crimp on tube or see box
Inactive Ingredients

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

Principal Display Panel –

Stop Use and Ask A Doctor If
  • 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)
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.


Structured Label Content

Uses
  • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps keep it from coming back
Section 42229-5 (42229-5)

Drug Facts

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Purpose

Antifungal

Warnings

For external use only

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

  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • pay special attention to the spaces between the toes
  • wear well fitting ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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.

Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Active Ingredient (Active ingredient)

Tolnaftate USP 1%

Other Information (Other information)
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • Lot No. and Exp date: see crimp on tube or see box
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel –

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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)
Keep This and All Drugs Out of the Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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