Active Ingredient Purpose

Allantoin 0.6% 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
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.

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

image description

TERRASIL DIABETICS ULCER AND SORE RELIEF KIT
allantoin kit

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-034-14	14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

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

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

Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(24909-039)