FUNGICURE ATHLETES FOOT- tolnaftate cream

Fungicure Athletes Foot by

Drug Labeling and Warnings

Fungicure Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Tolnaftate 1% w/v.

PURPOSE

Purpose

Antifungal

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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

Inactive ingredient

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

QUESTIONS

Questions? 1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGICURE ATHLETES FOOT 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1390-32	1 in 1 CARTON	12/12/2018
1		12 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/12/2018

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-1390)