SIGNATURE ATHLETES FOOT ANTIFUNGAL- tolnaftate powder 
Formulated Solutions, LLC

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Signature Athletes Foot Tolnaftate Antifungal

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

  • avoid contact with the eyes
  • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not punture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

store at 20-25°C (68-77°F)

Inactive Ingredients

alcohol denat, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monoleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Package Labeling:

Signature 814

SIGNATURE ATHLETES FOOT ANTIFUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-814
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ISOBUTANE (UNII: BXR49TP611)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SORBITAN (UNII: 6O92ICV9RU)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23667-814-01130 g in 1 CAN; Type 0: Not a Combination Product01/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00501/21/2017
Labeler - Formulated Solutions, LLC (143266687)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture(23667-814)

Revised: 12/2023
Document Id: 0b82635d-60b7-820c-e063-6294a90ac036
Set id: 46c6362f-265b-36b8-e054-00144ff8d46c
Version: 2
Effective Time: 20231202
 
Formulated Solutions, LLC