TERRASILMED BURN CARE- allantoin,menthol ointment

TerrasilMed BURN CARE by

Drug Labeling and Warnings

TerrasilMed BURN CARE by is a Otc medication manufactured, distributed, or labeled by Aidance Skincare & Topical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Allantoin 0.5%, Menthol 0.15%

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.

Keep out of reach of children.

If swallowed, consult a physician.

If pregnant or breast-feeding contact physician prior to use.

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

Product label

INGREDIENTS AND APPEARANCE

TERRASILMED BURN CARE 
allantoin,menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
SILVER STEARATE (UNII: 4H6PCL92ZN)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-027-50	50 g in 1 TUBE; Type 0: Not a Combination Product	11/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/25/2024

Labeler - Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-027)