Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5fc47184-82ae-4a0a-8f66-dfa03b1c5883
Route
TOPICAL
Published
Effective Date 2010-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Alcohol Glycerin Glyceryl Monostearate Paraffin Stearic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-08-27

Description

Antifungal

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Antifungal

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

Warning

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 of 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 2 ° and 30 ° C (36 ° and 86 ° F)

Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Carbomer, Cetyl alcohol, Cholesterol, 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

Tolnaftate

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

Warning

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 of 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 2 ° and 30 ° C (36 ° and 86 ° F)

Active Ingredients

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

Carbomer, Cetyl alcohol, Cholesterol, 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

Tolnaftate

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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