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Tolnaftate by Kareway Product, Inc.

Medically reviewed on July 24, 2017

Dosage form: cream
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Kareway Product, Inc.
NDC Code: 67510-0057

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Purpose

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

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

Do not use

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

Keep out of reach of children

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

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

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

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

Active Ingredients

Tolnaftate 1%

Principal Display Panel

Tolnaftate

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0057
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PARAFFIN 
STEARIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0057-11 TUBE in 1 BOX
128 g in 1 TUBE
2NDC:67510-0057-61 TUBE in 1 BOX
220 g in 1 TUBE
3NDC:67510-0057-51 TUBE in 1 BOX
314 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/11/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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