FDA Label for Fungazoil Advanced

View Indications, Usage & Precautions

Fungazoil Advanced Product Label

The following document was submitted to the FDA by the labeler of this product Pedifix. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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.


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