FUNGOID-D- tolnaftate cream

Fungoid-D by

Drug Labeling and Warnings

Fungoid-D by is a Otc medication manufactured, distributed, or labeled by Pedinol Pharmacal, Inc., EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

FUNGOID-D 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0884-8211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0884-8211-04	113 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/01/2011

Labeler - Pedinol Pharmacal, Inc. (064737125)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Contract Packaging		048602791	MANUFACTURE(0884-8211)