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.

Inactive Ingredients

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

Other information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Product label

TERRASILMED ONC
allantoin ointment

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-029)

Drug Facts