FORMUCARE ATHLETES FOOT MAXIMUM STRENGTH- tolnaftate spray 
Access Business Group LLC

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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Access Business Group LLC Athlete's Foot Spray Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

•
proven clinically effective in the treatment of most
•
athlete’s foot (tinea pedis)
•
ringworm (tinea corporis)
•
effectively soothes and relieves
•
itching
•
burning
•
cracking
•
helps prevent most athlete’s foot from coming back with daily use

Warnings

For external use only

Flammable: Do not use near flame or spark or while smoking.

Do not use

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

When using this product

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

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.

Directions

•
clean the affected area and dry thoroughly
•
shake can well before use
•
hold can about 6 inches from the area to be treated
•
spray a thin layer over the 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 toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
•
use daily for 4 weeks. If condition lasts longer, ask a doctor.
•
to prevent athlete’s foot, apply to the feet 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 a pin

Inactive ingredients

alcohol SD 40-B, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propane, propylene carbonate, sorbitan monooleate, stearalkonium hectorite, talc

Questions or comments?

1-800-719-9260

Principal Display Panel

tolnaftate 1%

antifungal

athlete's foot spray

powder spray

cures & prevents most athlete’s foot

relieves itching & burning

Athlete's Foot Spray Label

Athlete's Foot Spray Label

Athlete's Foot Spray Label

FORMUCARE ATHLETES FOOT  MAXIMUM STRENGTH
tolnaftate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-205
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
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ISOBUTANE (UNII: BXR49TP611)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPANE (UNII: T75W9911L6)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-205-90130 g in 1 CAN; Type 0: Not a Combination Product11/11/200407/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/11/200407/31/2015
Labeler - Access Business Group LLC (839830713)

Revised: 11/2017
Document Id: 28cb69e7-c6c5-420a-a7b8-e3d49a0f9765
Set id: fc195010-24a5-4bf1-b9ee-7c54f53a88eb
Version: 3
Effective Time: 20171104
 
Access Business Group LLC