Active Ingredient
Clotrimazole 1%
Terrasil Folliculitis Cream
FDA Label NDC 24909-064
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 Folliculitis Cream (NDC 24909-064). 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, 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
Proven clinically effective in the treatment of most tinea corporis (ringworm). 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 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 2 weeks, discontinue use and consult a physician.
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 and dry affected skin. Apply a layer of cream over affected area twice daily (morning and night) for 4 weeks or as directed by a doctor. Supervise children in the use of this product. Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.
Inactive Ingredients
cottonseed oil*, emulsifying wax, jojoba oil, MCT oil*, peppermint oil, purified water, shea butter, silver stearate, sorbic acid, tea tree oil, zinc oxide
*may contain this ingredient
Questions?
401-432-7750 or www.aidance.com
* Please review the disclaimer below.
