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

Description

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

Purpose

Antifungal foot wipes


Medication Information

Purpose

Antifungal foot wipes

Description

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

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
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

Warnings

For External use only

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)
Active Ingredient

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

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


Structured Label Content

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
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

Purpose

Antifungal foot wipes

Warnings

For External use only

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)
Active Ingredient

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)