FDA Label for Fungizyl Ac

Description:

Fungizyl AC™ is a topical antifungal formulation that combines Dimethyl Sulfoxide (DMSO) and Miconazole Nitrate with a mixture of emollients and essential oils. The formulation is designed to provide effective antifungal activity while also soothing and moisturizing the skin.

Each gram of Fungizyl AC™ contains 20 mg of Dimethyl Sulfoxide and 20 mg of Miconazole Nitrate in a vehicle with Aleurites Moluccana (Kukui) Seed Oil, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cety Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Sodium Hydroxide, and Stearyl Alcohol.

Indications:

Fungizyl AC™ is indicated for the treatment of fungal infections of the skin, including athlete's foot, jock itch, and ringworm. It also helps with superficial skin infections caused by Candida species. Dimethyl Sulfoxide (DMSO) enhances the penetration of Miconazole Nitrate through the skin, improving antifungal effectiveness.

Mechanism Of Action:

Miconazole Nitrate: An antifungal agent that inhibits the biosynthesis of ergosterol, a key component of fungal cell membranes, resulting in increased cell permeability and leakage of cellular contents. Dimethyl Sulfoxide (DMSO): A penetration enhancer that increases the absorption of Miconazole Nitrate through the skin, allowing for deeper antifungal action.

Pharmacokinetics:

When applied topically, miconazole nitrate exhibits minimal systemic absorption. Most of the drug remains on the skin surface and provides localized antifungal activity.

Contraindications:

This product is contraindicated in patients with known hypersensitivity to any of its ingredients.

Warnings:

For external use only. Not for ophthalmic use.

Precautions:

Allergic Reactions: Hypersensitivity reactions, including severe allergic contact dermatitis and anaphylactic reactions, have been reported with miconazole use. Discontinue use immediately if signs of hypersensitivity occur.

Use In Pregnancy:

Category C: There are no adequate and well-controlled studies of miconazole nitrate or DMSO use in pregnant women. It should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Pediatric Use:

Safety and efficacy in children have not been established.

Adverse Reactions:

The most common side effects reported during the use of miconazole-containing products are local irritation, burning, stinging, redness, or swelling at the application site.

Dosage And Administration:

• Clean the affected area and dry thoroughly. Apply a thin layer of Fungizyl AC™ over the affected area twice daily (morning and evening) or as directed by a licensed healthcare practitioner. • Continue treatment for at least 2 weeks, even if symptoms improve, to reduce the likelihood of recurrence. • If there is no improvement after 4 weeks of treatment, discontinue use and consult a licensed healthcare practitioner.

How Supplied:

Fungizyl AC™ is supplied in a 3 oz. (85 g) tube with a CRC cap (NDC 59088-206-07).

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed.

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