FUNGICURE ATHLETES FOOT- tolnaftate cream 
Denison Pharmaceuticals, 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.

----------

Fungicure Athlete's Foot Cream

Active ingredient

Tolnaftate 1% w/v.

Purpose

Antifungal

Keep out of reach of children. If swallowed, get medical help or contact a poison center right away.

Uses

For the cure of most:

  • athlete's foot (tinea pedis)
  • ringworm (tinea corporis)

For relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • discomforts which may accompany these conditions. Clears up most athlete's foot infections and with daily use helps them from coming back.

Warnings

For external use only.

Ask a doctor before use on children under 2 years of age.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Inactive ingredient

Butylated hydroxytoluene, menthol, PEG-75, PEG-400, titanium dioxide, white petrolatum

Directions

  • Read and all package directions and warnings before use.
  • Use only as directed.
  • Clean the affected area with soap with warm water and dry thoroughly.
  • Apply a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor.
  • This product is not effective on scalp or nails.
  • 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.
  • For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Intented for use by normally healthy adults only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Supervise children in the use of this product.

Other information

  • You may report serious side effects to the phone number provided under Questions? below

Questions? 1-800-792-2582

label

FUNGICURE ATHLETES FOOT 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1390
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
PETROLATUM (UNII: 4T6H12BN9U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1390-321 in 1 CARTON12/12/2018
112 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/12/201801/13/2022
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-1390)

Revised: 1/2022
 
Denison Pharmaceuticals, LLC