LEADER ANTIFUNGAL TOLNAFTATE  - tolnaftate cream 
CARDINAL HEALTH

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.

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Active Ingredient                                                                              Purpose

Tolnaftate 1% .................................................................................Antifungal

Uses

Warnings

For external use only

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

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

Other Information

Lot No. and Exp. Date: see box or see crimp of the tube.  Store between 20o to 25oC (68o to 77oF)

Inactive Ingredients

Propylene glycol, liquid paraffin, stearyl alchol, cetyl alcohol, sorbitan monstearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 2534121

www.myleader.com

1-800-200-6313

Made in Korea

image of carton labelEnter section text here


LEADER ANTIFUNGAL TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-097
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
MINERAL OIL 
STEARYL ALCOHOL 
CETYL ALCOHOL 
SORBITAN MONOSTEARATE 
WATER 
METHYLPARABEN 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:37205-097-101 TUBE ( TUBE) in 1 CARTONcontains a TUBE
128 g in 1 TUBEThis package is contained within the CARTON (37205-097-10)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2012

Labeler - CARDINAL HEALTH (097537435)

Revised: 03/2012 CARDINAL HEALTH