cde656a9-7841-4a73-a2f4-f5a76a3e15c1

SPL v3
SPL
SPL Set ID cde656a9-7841-4a73-a2f4-f5a76a3e15c1
Route
topical
Published
Effective Date 2022-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
tolnaftate (10 g)
Inactive Ingredients
water sodium hydroxide polysorbate 80 polysorbate 20 propylene glycol butylated hydroxytoluene eucalyptus oil 3-((l-menthyl)oxy)propane-1,2-diol menthol peppermint oil phenoxyethanol caprylyl glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-01-27
Purpose

Antifungal foot wipes

Description

Tolnaftate 1%.........................Purpose: Antifungal

Medication Information

Warnings

For External use only

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corpois)
  • prevents most athlete's foot (tinea pedis) and ringworm (tinea corpois) with daily use
  • for effective relief of itching, burning, cracking, scaling, and discomfort which accompany these conditions
Purpose

Antifungal foot wipes

Directions
  • wash affected area and dry thoroughly
  • use the pad to cleanse and cover the affected area with a thin layer twice daily (morning and night)
  • pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • supervise children in the use of this product
  • for treatment of athlete's foot and ringworm, use daily for 4 weeks.
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
Other Information
  • KEEP TIGHTLY CLOSED
  • do not flush pads in toilet
  • store between 20° ro 25°C (68° to 77°F)
Inactive Ingredients

Butylated Hydroxytoluene, Caprylyl Glycol, Eucalyptus Oil, Menthol, Menthoxypropanediol, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Polysorbate 80, Proylene Glycol, Sodium Hydroxide, Water

Description

Tolnaftate 1%.........................Purpose: Antifungal

Section 50565-1

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

Section 50566-9
Stop use and ask a doctor if
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm)
Section 50567-7

When using this product avoid contact with the eyes

Section 50570-1

Do not use on children under 2 years of age unless otherwise directed by a doctor

Section 51945-4

Section 53413-1

Questions?     1-866-360-3226

Active Ingredient

Tolnaftate 1%.........................Purpose: Antifungal

Structured Label Content

Warnings

For External use only

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corpois)
  • prevents most athlete's foot (tinea pedis) and ringworm (tinea corpois) with daily use
  • for effective relief of itching, burning, cracking, scaling, and discomfort which accompany these conditions
Purpose

Antifungal foot wipes

Directions
  • wash affected area and dry thoroughly
  • use the pad to cleanse and cover the affected area with a thin layer twice daily (morning and night)
  • pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • supervise children in the use of this product
  • for treatment of athlete's foot and ringworm, use daily for 4 weeks.
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
Other Information
  • KEEP TIGHTLY CLOSED
  • do not flush pads in toilet
  • store between 20° ro 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

Butylated Hydroxytoluene, Caprylyl Glycol, Eucalyptus Oil, Menthol, Menthoxypropanediol, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Polysorbate 80, Proylene Glycol, Sodium Hydroxide, Water

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)
Stop use and ask a doctor if
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm)
Section 50567-7 (50567-7)

When using this product avoid contact with the eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless otherwise directed by a doctor

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?     1-866-360-3226

Active Ingredient

Tolnaftate 1%.........................Purpose: Antifungal

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:30.275200 · Updated: 2026-03-14T23:07:24.321893