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                                    Purpose

Allantoin 0.5%                                       Skin Protectant
Menthol 0.15%                                      Topical Analgesic

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

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

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)
PETROLATUM (UNII: 4T6H12BN9U)
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	05/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/08/2023

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

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