SPL v3
SPL
SPL Set ID 46b58c71-d62e-4b3d-b2ec-65407032eeea
Route
TOPICAL
Published
Effective Date 2022-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-30

Description

Tolnaftate 1% 

Purpose

Antifungal 


Medication Information

Purpose

Antifungal 

Description

Tolnaftate 1% 

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 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.

Active 

Tolnaftate 1% 

Purpose 

Antifungal 

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.
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).
Inactives 

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

Questions ?

1-800-222-1087

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

WINCO NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

Principal Display Panel Carton 

WINCO                                    NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%) 

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 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 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.

Active 

Tolnaftate 1% 

Purpose 

Antifungal 

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.
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).
Inactives 

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

Questions ?

1-800-222-1087

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

WINCO NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

Principal Display Panel Carton  (Principal Display panel -Carton )

WINCO                                    NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%) 

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)


Advanced Ingredient Data


Raw Label Data

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