Skip to Content

← See all Leader Medicated brands

Leader Medicated by Cardinal Health Inc.

Medically reviewed on October 9, 2017

Dosage form: aerosol, powder
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Cardinal Health Inc.
NDC Code: 37205-344

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

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

  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • if used daily, can prvent recurrance of athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning and cracking

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
  • wash affected area and dry thoroughly
  • shake can well and spray 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 toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if condition persists, consult a doctor
  • to prevent athlete's foot, apply daily (morning and night)
  • this product is not effective on scalp or nails
  • in case of clogging, clear nozzle under running water

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 Medicated Tolnaftate 1% Powder Spray

LEADER MEDICATED 
tolnaftate aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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/FEIOperations
Premier Brands of America063849780repack(37205-344), relabel(37205-344)
Establishment
NameAddressID/FEIOperations
American Spray Tech LLC137135237manufacture(37205-344)

 
Cardinal Health Inc.

← See all Leader Medicated brands

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.

Hide