Terrasilmed Burn Care
FDA Label NDC 24909-027

10 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 Terrasilmed Burn Care (NDC 24909-027). 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, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Allantoin 0.5% - Skin Protectant

Menthol 0.15% - Topical Analgesic

Uses

Helps protect skin and provide temporary relief of pain and itching due to minor burns, sunburn, and skin irritations.

Warnings

For external use only.

When using this product, do not get into eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than 7 days discontinue use and consult physician.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician. ​Store at room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.

Inactive Ingredients

beeswax, MCT (coconut oil), silver stearate, sorbic acid

Questions?

401-432-7750 or www.aidance.com

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