Terrasilmed Burn Care
FDA Label NDC 24909-027

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 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, directions, inactive ingredients, questions?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients                                    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 seven days discontinue use and consult physician.

If pregnant or breastfeeding, contact physician prior to use.

Keep out of reach of children. If swallowed, consult a 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, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid

Questions?

401-432-7750 or www.aidance.com

Product Label

Image Description (Burn Care Image)

Image Description (Burn Care Image)

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