Active Ingredients
Ointment: Clotrimazole 1%
Soap Bar: Clotrimazole 1%
Terrasil Fungal Treatment Kit
FDA Label NDC 24909-046
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 Fungal Treatment (NDC 24909-046). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, other safety information, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
Treats Athlete’s foot (tinea pedis), Jock itch (tinea cruris),
Ringworm (tinea corporis). Relieves Itching, burning, cracking.
Warnings
For external use only.
Do not use on children under two years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 4 weeks, or 2 weeks for jock itch, discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Wash affected area well with soap, rinse area after one to two minutes. Dry thoroughly. Apply a layer of ointment over affected area. Use twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete’s foot: Pay special attention to spaces between the 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. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. For best results use both Terrasil Antifungal Ointment and Soap Bar. Store at room temperature. Ointment may temporarily (washable) discolor skin, nails, and fabrics in sunlight.
Inactive Ingredients
Ointment: beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)* witch hazel, zinc oxide
Soap Bar: beeswax, citric acid, glycerin, jojoba oil, lavender oil, magnesium oxide, MCT oil, peppermint oil, propylene glycol, silver stearate, sodium chloride, sodium citrate, sodium laurate, sodium laureth sulfate, sodium lauryl sulfate, sodium myristate, sodium oleate, sodium olivate, sodium shea butterate, sodium stearate, sorbitol, tea tree oil, tetrasodium etidronate, tetrasodium iminodisuccinate, titanium dioxide, water, zinc oxide
*may contain this ingredient
Other
Retain Carton for Product Information
Questions? 401-432-7750 or www.aidance.com
* Please review the disclaimer below.
