FUNGAZOIL ADVANCED- clotrimazole 1% liquid

FungaZoil Advanced by

Drug Labeling and Warnings

FungaZoil Advanced by is a Otc medication manufactured, distributed, or labeled by Pedifix, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

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

When using this product avoid contact with eyes

Stop use and as doctor if irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)

If swallowed, get medical help or contact a Poison control center immediately.

Active Ingredient

Clotrimazole 1%

Inactive ingredients

Aqua (Deionized Water), BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl Acetate (Vitamin- E), Urea.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Purpose

Antifungal

Uses

For the cure of most
athlete’s foot (tinea pedis)
ringworm (tinea corporis)
jock itch (tinea cruris) For relief of
itching scaling cracking burning redness soreness irritation
discomforts which may accompany these conditions.

Directions

Read all package directions and warnings before using.
Use only as directed.
Clean the affected area with soap and warm water and dry thoroughly.
Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.
This product is not effective on the scalp or nails.
Avoid applying to severely cracked or irritated areas.
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; for jock itch, use daily for 2 weeks.
Super vise children in the use of this product.
Intended for use by normally healthy adults only.
Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Other Information
Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAZOIL ADVANCED 
clotrimazole 1% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68927-3492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SAFFLOWER OIL (UNII: 65UEH262IS)
EMU OIL (UNII: 344821WD61)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
SOYBEAN OIL (UNII: 241ATL177A)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALMOND OIL (UNII: 66YXD4DKO9)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
JOJOBA OIL (UNII: 724GKU717M)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68927-3492-1	15 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/15/2014

Labeler - Pedifix (122271935)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		969241041	manufacture(68927-3492)