Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0c3c9fdd-9fc6-6c8a-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2012-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Cetyl Alcohol Glycerin Glyceryl Monostearate Paraffin Stearic Acid Water Chlorocresol Sodium Phosphate, Dibasic Myristoyl/palmitoyl Oxostearamide/arachamide Mea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-01-07

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Uses
  • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevnet most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

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

Do Not Use

on children under 2 years of age except under the advice and supervision of a doctor

Other Information
  • store between 36° and 86°F (2° and 30°C)

Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Carbomer, Cetyl alcohol, Chlorocresol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevnet most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

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

Do Not Use (Do not use)

on children under 2 years of age except under the advice and supervision of a doctor

Other Information
  • store between 36° and 86°F (2° and 30°C)

Active Ingredients

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

Carbomer, Cetyl alcohol, Chlorocresol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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