TERRASILMED ONC- allantoin ointment

TerrasilMed ONC by

Drug Labeling and Warnings

TerrasilMed ONC by is a Otc medication manufactured, distributed, or labeled by Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Helps prevent, temporarily protect, and relieve cracked skin.

Warnings

For external use only. When using this product, do not get into eyes. Stop use and ask a doctor ifcondition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Consult a doctor before using on deep puncture wounds or serious burns.

Keep out of reach of children.

If swallowed, call Poison Control or seek medical help.

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive ingredients

beeswax, MCT (coconut oil), peppermint oil, petrolatum, silver oxide, sorbic acid, stearic acid

Other information

Questions? 401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASILMED ONC 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-029
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

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
SILVER OXIDE (UNII: 897WUN6G6T)
SORBIC ACID (UNII: X045WJ989B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-029-50	50 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	09/16/2023

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(24909-029)