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FUNGOID-D (tolnaftate) cream
[Pedinol Pharmacal, Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Facts

Active Ingredient

Tolnaftate1%

Purpose

Antifungal

Uses

  • prevents the recurrence of most athlete's foot (tinea pedis) with daily use.
  • clears up most athlete's foot infection and with daily use helps keep it from coming back.

Warnings

For external use only

When using this product

  • do not use on children under 2 years of age unless directed by a doctor.
  • avoid contact with the eyes.
  • if irritation occurs, discontinue use and consult a doctor.
  • if swallowed, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Directions

  • to prevent athlete's foot clean the feet and dry thoroughly.
  • apply a thin layer of the product to the feet once or twice daily (morning and/or night).
  • supervise children in the use of this product.
  • pay special attention to spaces between the toes.
  • wear well-fitting, ventilated shoes and change shoes and socks at least once daily.

Other Information

Store at controlled room temperature 15°- 30°C (59°- 86°F).

Inactive Ingredients

Aloe barbadensis (aloe vera) leaf juice, beeswax, cetyl alcohol, citric acid, diazolidinyl urea, DMDM hydantoin, melaleuca alternifolia (tea tree) flower/leaf/stem extract, methylparaben, microcrystaline wax, mineral oil, propylene glycol, propylparaben, sodium lauryl sulfate, stearyl alcohol, triethanolamine, urea, water

Questions or Comments?

Please call 1-800-PEDiNOL (733-4665).

Monday – Friday, 9 AM until 5 PM EST, except holidays or visit us online at www.pedinol.com.

Manufactured for:
PEDiNOL™ Pharmacal Inc.
Farmingdale, NY 11735

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

NDC 0884-8211-04

PEDiNOL

fungoid-D™
tolnaftate 1%

antifungal cream
in a moisturizing base

prevents most athlete's foot
& hydrates dry skin
with daily use

net. wt. 4oz. (113g)

Principal Display Panel

INGREDIENTS & APPEARANCE

FUNGOID-D 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0884-8211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
YELLOW WAX 
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
DMDM HYDANTOIN 
MELALEUCA ALTERNIFOLIA LEAF 
METHYLPARABEN 
MICROCRYSTALLINE WAX 
MINERAL OIL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
STEARYL ALCOHOL 
TROLAMINE 
UREA 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0884-8211-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/01/2011
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIBusiness Operations
EMS Contract Packaging048602791MANUFACTURE

Revised: 2/2012
 
Pedinol Pharmacal, Inc.