Target

Target
SPL v5
SPL
SPL Set ID f55c691f-5265-4574-8dc5-aa86b0a8edd2
Route
TOPICAL
Published
Effective Date 2023-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Butylated Hydroxytoluene Polyethylene Glycol 400 Polyethylene Glycol 3350 Titanium Dioxide Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-02-17

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this productavoid contact with eyes

Section 50570-1

Do not useon children under 2 years of age except under the advice and supervision of a doctor.

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
Questions?

Call 1-800-910-6874

Active Ingredient

Tolnaftate 1%

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks
Principal Display Panel 30 G Tube Carton

up&up

antifungal cream

tolnaftate 1%

cures and prevents most athlete's foot and ringworm

helps relieve itching and burning

NET WT 1 OZ (30 g)


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5 (42229-5)

Drug Facts

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 50567-7 (50567-7)

When using this productavoid contact with eyes

Section 50570-1 (50570-1)

Do not useon children under 2 years of age except under the advice and supervision of a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
Questions?

Call 1-800-910-6874

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks
Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

up&up

antifungal cream

tolnaftate 1%

cures and prevents most athlete's foot and ringworm

helps relieve itching and burning

NET WT 1 OZ (30 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)