LEADER MEDICATED- tolnaftate aerosol, powder 
Cardinal Health Inc.

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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Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor

Uses

Uses

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120o F

When using this product

  • do not get into eyes or mouth
  • use only as directed; intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal

​Stop use and ask a doctor if

  • irritation occurs
  • no improvement after four weeks for athlete's foot,

Directions

Other infomation

Store between 20o and 30o C (68o and 86o F)

Inactive ingredients

SD alcohol 40-B (14% w/w), BHT, Isobutane (propellant), PPG-12-buteth-16, talc

Questions

Call 1-866-964-0939

Box Label

Leader Tolnaftate 1%  Medicated Powder SprayLeader Medicated Tolnaftate 1% Powder Spray

LEADER MEDICATED 
tolnaftate aerosol, powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL0.14 g  in 1 g
ISOBUTANE 
PPG-12-BUTETH-16 
TALC 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-344-66130 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/15/2008
Labeler - Cardinal Health Inc. (097537435)
Registrant - Premier Brands of America (063849780)
Establishment
NameAddressID/FEIBusiness Operations
Premier Brands of America063849780repack(37205-344), relabel(37205-344)
Establishment
NameAddressID/FEIBusiness Operations
American Spray Tech LLC137135237manufacture(37205-344)

Revised: 10/2012
Document Id: e606ab2f-28af-48f7-ab95-bf697e2d9f00
Set id: 61442754-d723-40b7-b129-2b641cfd9ef7
Version: 6
Effective Time: 20121008
 
Cardinal Health Inc.