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Tolnaftate Antifungal by Taro Pharmaceuticals U.S.A., Inc.

Medically reviewed on January 31, 2018

Dosage form: cream
Ingredients: Tolnaftate 1g in 100g
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2020

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.

Tolnaftate Antifungal Cream 1%

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

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

Warnings

For external use only

When using this product avoid contact with 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 or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

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

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Cures & Prevents Most Athlete's Foot

Antifungal Cream

Tolnaftate Cream 1%

Antifungal

NET WT 1 oz (30 g)

TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
butylated hydroxytoluene 
polyethylene glycol 400 
polyethylene glycol 3350 
titanium dioxide 
petrolatum 
Product Characteristics
ColorWHITE (opaque, white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2020-11 TUBE in 1 CARTON
115 g in 1 TUBE
2NDC:51672-2020-21 TUBE in 1 CARTON
230 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/01/1995
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2020)

 
Taro Pharmaceuticals U.S.A., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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