SPL v3
SPL
SPL Set ID e3ebce6f-88ca-4100-ac79-d300f44e4891
Route
TOPICAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Tetrasodium Glutamate Diacetate Eucalyptus Oil Water Sodium Gluconate Sodium Palm Kernelate Glycerin Melaleuca Alternifolia Leaf Sodium Chloride Activated Charcoal Sodium Cocoate Sodium Palmate Sodium Laureth Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-06
Description

Tolnaftate 1.0%

Purpose

Antifungal

Medication Information

Warnings and Precautions

Warning

For external use only.

When using this product

When using this product avoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no

improvement within 2 weeks for jock itch or within 4 weeks for athlete's

foot and ringworm.

Do not use

Do Not use on children under 2 under of age except under the advice

and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antifungal

Description

Tolnaftate 1.0%

Uses

For treatment of most

  • jock itch
  • ringworm
  • atheletes foot
  • tinea versicolor

Relieves

  • itching
  • scaling
  • burning
  • redness
  • cracking
  • associated discomfort
Section 50565-1

Directions
  • Make sure to dry affected area thoroughly.
  • 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 and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.
Product Label

Active Ingredient

Tolnaftate 1.0%

Inactive Ingredients

TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE

Structured Label Content

Uses

For treatment of most

  • jock itch
  • ringworm
  • atheletes foot
  • tinea versicolor

Relieves

  • itching
  • scaling
  • burning
  • redness
  • cracking
  • associated discomfort
Warnings and Precautions (34071-1)

Warning

For external use only.

When using this product

When using this product avoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no

improvement within 2 weeks for jock itch or within 4 weeks for athlete's

foot and ringworm.

Do not use

Do Not use on children under 2 under of age except under the advice

and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Purpose

Antifungal

Directions
  • Make sure to dry affected area thoroughly.
  • 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 and change shoes and socks at least once daily.
  • Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.
Product Label (Product label)

Active Ingredient (Active ingredient)

Tolnaftate 1.0%

Inactive Ingredients (Inactive ingredients)

TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:37.363387 · Updated: 2026-03-14T23:07:45.169331