TERRASIL DIABETICS ULCER AND SORE RELIEF KIT- allantoin kit

terrasil Diabetics Ulcer and Sore Relief Kit by

Drug Labeling and Warnings

terrasil Diabetics Ulcer and Sore Relief Kit 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                                  Purpose

Allantoin 0.6%                                 Skin Protectant

PURPOSE

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  
• symptoms clear up and occur again within a few days.

Consult a doctor before using

• on deep or puncture wounds
• animal bites 
• 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 as needed. 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 DIABETICS ULCER AND SORE RELIEF KIT 
allantoin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-039

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-039-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	03/18/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	14 g
Part 2	1 BOX	75 g

Part 1 of 2

TERRASIL DIABETICS ULCER AND SORE RELIEF 
allantoin ointment

Product Information
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
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016

Part 2 of 2

TERRASIL DIABETICS CLEANSING BAR 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)]

Product Information

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		10/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/18/2024

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(24909-039)