TERRASIL DIABETICS ULCER AND SORE RELIEF- allantoin ointment

terrasil Diabetics Ulcer and Sore Relief by

Drug Labeling and Warnings

terrasil Diabetics 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 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 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.

Other information

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

STORAGE AND HANDLING

Store at room temperature.

Product label

INGREDIENTS AND APPEARANCE

TERRASIL DIABETICS ULCER AND SORE RELIEF 
allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-034
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
STEARIC ACID (UNII: 4ELV7Z65AP)
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: 24909-034-14	14 g in 1 TUBE; Type 0: Not a Combination Product	05/15/2024
2	NDC: 24909-034-44	44 g in 1 JAR; Type 0: Not a Combination Product	05/15/2024
3	NDC: 24909-034-28	28 g in 1 TUBE; Type 0: Not a Combination Product	05/05/2025

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	manufacture(24909-034)