FUNGOID-D- tolnaftate cream 
Pedinol Pharmacal, Inc.

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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Drug Facts

Active ingredient

Tolnaftate 1%

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

Do not use

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

When using this product

•
avoid contact with the eyes.
•
if irritation occurs, discontinue use and consult a doctor.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 1-800-321-4576

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

PRINCIPAL DISPLAY PANEL - 4 oz. (113 g) Carton

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. 4 oz. (113 g)

Pedinol Fungoid-D - 4 oz (113 g) - Carton
FUNGOID-D 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-8211
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0884-8211-04113 g in 1 TUBE; Type 0: Not a Combination Product08/01/201103/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/01/201103/31/2019
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIBusiness Operations
EMS Contract Packaging048602791MANUFACTURE(0884-8211)

Revised: 12/2018
Document Id: 96a91104-ef46-4fa3-bf98-4264c326fae7
Set id: b0d1285b-0f87-4eed-8da6-bb5c77309eca
Version: 4
Effective Time: 20181203
 
Pedinol Pharmacal, Inc.