Active Ingredients
Allantoin 0.5%, Menthol 0.15%
Terrasil Itch, Rash And Pain Relief Maximum Strength
FDA Label NDC 24909-160
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 Skincare & Topical Solutions, Llc for the product Terrasil Itch, Rash And Pain Relief Maximum Strength (NDC 24909-160). 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, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Allantoin - Skin Protectant
Menthol - Topical Anesthetic
Uses
For temporary relief and protection from pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.
Warnings
For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. If pregnant or breast feeding, contact physician prior to use.
Keep out of reach of children. If swallowed, consult physician.
Directions
Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. Store at room temperature. May stain fabrics.
Inactive Ingredients
beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.
**may contain this ingredient.
Principal Display Panel
All Natural
terrasil®
ITCH, RASH & PAIN RELIEF OINTMENT
MAXIMUM STRENGTH
with Activated Minerals®
Terrasil (24909 160)
* Please review the disclaimer below.
