TERRASIL BED SORE AND PRESSURE SORE RELIEF- allantoin ointment

terrasil Bed Sore and Pressure Sore Relief by

Drug Labeling and Warnings

terrasil Bed Sore and Pressure Sore Relief 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 0.6%

Purpose

Skin Protectant

Uses

Helps prevent, temporarily protect, and relieve chapped or 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 usingon deep or puncture wounds, animal bites or serious burns. Keep out of reach of children.If swallowed, call Poison Control or seek medical help.

KEEP OUT OF REACH OF CHILDREN

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Cover with a clean bandage. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

Inactive Ingredients

beeswax, calendula extract, coconut oil (organic), comfrey extract, cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, sunflower oil, tea tree oil, thuja extract, zinc oxide

Other information

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

Product label

INGREDIENTS AND APPEARANCE

TERRASIL BED SORE AND PRESSURE SORE RELIEF 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COCONUT OIL (UNII: Q9L0O73W7L)
COMFREY ROOT (UNII: M9VVZ08EKQ)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PALM OIL (UNII: 5QUO05548Z)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER STEARATE (UNII: 4H6PCL92ZN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-035-44	44 g in 1 JAR; Type 0: Not a Combination Product	05/15/2024
2	NDC: 24909-035-85	85 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/15/2024

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	label(24909-035) , manufacture(24909-035)