TERRASIL FOOT ULCER AND SORE RELIEF- allantoin ointment

terrasil Foot Ulcer and Sore Relief by

Drug Labeling and Warnings

terrasil Foot Ulcer and 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 ingredients

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 if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Consult a doctor before using on deep or puncture wounds, animal bites 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. Cover with a clean bandage. 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, 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, vegetable stearic acid (naturally sourced)*, zinc oxide

*May contain this ingredient

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TERRASIL FOOT ULCER AND SORE RELIEF 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-044
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
COCONUT OIL (UNII: Q9L0O73W7L)
PALM OIL (UNII: 5QUO05548Z)
SILVER STEARATE (UNII: 4H6PCL92ZN)
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COTTONSEED OIL (UNII: H3E878020N)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC OXIDE (UNII: SOI2LOH54Z)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SAGE OIL (UNII: U27K0H1H2O)
JOJOBA OIL (UNII: 724GKU717M)
PEPPERMINT OIL (UNII: AV092KU4JH)
COMFREY ROOT (UNII: M9VVZ08EKQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-044-44	44 g in 1 JAR; Type 0: Not a Combination Product	12/15/2024
2	NDC: 24909-044-85	85 g in 1 TUBE; Type 0: Not a Combination Product	12/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/15/2024

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	manufacture(24909-044) , label(24909-044)