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 Type HUMAN OTC DRUG Item Code (Source) NDC:37205-344
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M) 0.14 g  in 1 g
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-344-66 130 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 03/15/2008
Labeler - Cardinal Health Inc. (097537435)
Registrant - Premier Brands of America (063849780)
Establishment
Name Address ID/FEI Business Operations
Premier Brands of America 063849780 repack(37205-344) , relabel(37205-344)
Establishment
Name Address ID/FEI Business Operations
American Spray Tech LLC 137135237 manufacture(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.