TOLNAFTATE- antifungal powder spray aerosol, powder 
The Podiatree Company

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

Tolnaftate 1%

​Purpose

Antifungal

Uses

​Warnings

For external use only.

Flammable:

Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

​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 within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

​Keep out of reach of children.

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

​Directions

​Other information

Store between 20º and 30ºC (68ºF and 86ºF)

Inactive ingredient

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

Questions or Suggestions?

1.855.763.8733 or www.thepodiatreecompany.com. Our commitment to you is 100%

satisfaction. If you are not completely satisf ied, please contact us directly for a full refund.

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label

TOLNAFTATE 
antifungal powder spray aerosol, powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-913
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ISOBUTANE (UNII: BXR49TP611)  
PPG-12-BUTETH-16 (UNII: 58CG7042J1)  
ALCOHOL (UNII: 3K9958V90M)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54633-913-04130 g in 1 CANISTER; Type 0: Not a Combination Product07/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/01/2013
Labeler - The Podiatree Company (078656000)

Revised: 12/2017
Document Id: 60b9aa2d-ae5b-567b-e053-2a91aa0a1e29
Set id: 60b9aa2d-ae5c-567b-e053-2a91aa0a1e29
Version: 3
Effective Time: 20171219
 
The Podiatree Company