FDA Label for Terrasil Serious Tinea Treatment
View Indications, Usage & Precautions
Terrasil Serious Tinea Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Aidance Skincare & Topical Solutions, Llc. 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.
Active Ingredient
Ointment: Clotrimazole 1%
Cleansing Bar: Thuja Occidentalis 6X HPUS
The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.
Purpose
Antifungal
Uses
Ointment: Clears up tinea fungal infections including tinea corporis, tinea crursis, and tinea pedis. For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort, redness and chafing associated with fungal skin infections.
Cleansing Bar: For most fungal infection.
Warnings
For external use only.
Do not use on 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 4 weeks, discontinue use and consult a physician.
Keep out of reach of children. If swallowed, call poison control or seek medical help.
Directions
Ointment: Wash and dry affected skin. Massage oinment in to affected skin. Reapply up to 4 times daily. Supervise children in the use of this product. Store at room temperature. May stain fabrics.
Cleansing Bar: Wash affected area daily.
Inactive Ingredients
Ointment: beeswax (organic), bentonite (volcanic clay)*, cedarwood oil, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.
Cleansing Bar: beeswax (organic), bentonite (volcanic clay), coconut oil, glycerin, jojoba oil, lauric acid, lavender oil, magnesium oxide, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, shea butter, silver oxide, sodium chloride, sodium citrate, sodium hydroxide, sodium laurate, SLES, SLS, sodium olivate, sodium palm kernelate, sodium palmate, sodium stearate, sorbitol, stearic acid, tea tree oil, tetrasodium etidronate, titanium dioxide, water, zinc oxide.
*may contain this ingredient.
Principal Display Panel
SERIOUS TINEA TREATMENT
2 PRODUCT SYSTEM
All Natural
terrasil®
1> Anti-Tinea Ointment
2> Anti-Fungal Cleansing Bar
* Please review the disclaimer below.