The following Structured Product Label (SPL) was submitted to the FDA by Pedifix for the product Fungazoil Advanced (NDC 68927-3492). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, active ingredient, inactive ingredients, otc - keep out of reach of children, purpose, uses, directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Clotrimazole 1%
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
Antifungal
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.
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.
* Please review the disclaimer below.
