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Signature Athletes Foot Antifungal

Medically reviewed on Jan 23, 2017

Dosage form: powder
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Formulated Solutions, LLC
NDC Code: 23667-814

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.

Signature Athletes Foot Tolnaftate Antifungal

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • proven clinically effective in the treatment of most athlet's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief if itching, burning, cracking

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
  • 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 the toas, wear well-fitting, ventilated shoes and change shoes and sucks at least once daily
  • use daily for 4 weeks; if condition persist longer, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
  • in case of clogging, clean nozzle with pin

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 ATHLETES FOOT ANTIFUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-814
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ALUMINUM STARCH OCTENYLSUCCINATE 
ISOBUTANE 
ISOPROPYL MYRISTATE 
PROPYLENE CARBONATE 
SORBITAN 
STEARALKONIUM HECTORITE 
TALC 
Packaging
#Item CodePackage Description
1NDC:23667-814-01130 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/21/2017
Labeler - Formulated Solutions, LLC (143266687)
Establishment
NameAddressID/FEIOperations
Formulated Solutions, LLC143266687manufacture(23667-814)

 
Formulated Solutions, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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