FUNGAZOIL ADVANCED- clotrimazole 1% liquid 
Pedifix

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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FungaZoil Advanced

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

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.

image description

FUNGAZOIL ADVANCED 
clotrimazole 1% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68927-3492
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68927-3492-115 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/15/2014
Labeler - Pedifix (122271935)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source969241041manufacture(68927-3492)

Revised: 6/2014
Document Id: 526db92b-9af6-4bf0-884c-c997b438f22d
Set id: babb5ca8-d608-4437-b35d-5133f7348d0c
Version: 1
Effective Time: 20140612
 
Pedifix