Active Ingredient
Clotrimazole 1%
Terrasil Tinea Treatment Ointment
FDA Label NDC 24909-104
8 label sections · Submitted to the FDA by Aidance Scientific, Inc., Dba Aidance Skincare & Topical Solutions · 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 Tinea Treatment (NDC 24909-104). 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, otc - keep out of reach of children, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
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.
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 4 weeks, discontinue use and consult a physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Wash and dry affected skin. Apply a thin layer of ointment over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May stain fabrics.
Inactive Ingredients
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
Product Label
Label (Image 1 20)
Tube Image (Image 1 15)
* Please review the disclaimer below.
