Terrasil The Fungal Solution Kit
FDA Label NDC 24909-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Scientific, Inc, Dba Aidance Skincare & Topical Solutions for the product Terrasil The Fungal Solution Kit (NDC 24909-038). 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 active ingredient                                  purpose, uses, warnings, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient                                  Purpose

Clotrimazole 1%                                Antifungal

Uses

Ointment: Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

Cleansing Bar: For relief of most fungal skin infection symptoms.

Warnings

For external use only.
Do not useon children under two years of age unless directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Ointment: Wash and dry affected skin. Apply a layer of ointment over affected area twice daily or as directed by a doctor. Supervise children in the use of this product.

Cleaning Bar: Wash affected area daily. For best results use with
terrasil® Antifungal ointment products.

Inactive Ingredients

Ointment: beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, witch hazel, zinc oxide

Cleansing Bar: beeswax (organic), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, olive oil, pentasodium pentetate, peppermint oil, shea butter (butyrospermum), silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Product Label

Image Description (Image 1)

Image Description (Image 1)

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