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terrasil Diabetics Ulcer and Sore Relief

24909-034 terrasil Diabetic's Ulcer & Bed Sore Relief

Approved
Approval ID

fd6bf169-f1e2-48d4-b98d-8f3c39981a89

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions

DUNS: 018950611

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ALLANTOIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24909-034
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALLANTOIN
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (17)

STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
COMFREY ROOTInactive
Code: M9VVZ08EKQ
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SAGE OILInactive
Code: U27K0H1H2O
Classification: IACT
SILVER STEARATEInactive
Code: 4H6PCL92ZN
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
THUJA OCCIDENTALIS LEAFInactive
Code: 0T0DQN8786
Classification: IACT
ZINC OXIDEInactive
Code: SOI2LOH54Z
Classification: IACT
ALLANTOINActive
Quantity: 0.6 g in 100 g
Code: 344S277G0Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

Product label

Tube Image

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/10/2023

Uses

Helps prevent, temporarily protect, and relieve chapped or cracked skin.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/15/2023

Active Ingredient

Allantoin 0.6%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/10/2023

Purpose

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 11/10/2023

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/10/2023

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 11/13/2023

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 SECTION

LOINC: 44425-7Updated: 1/10/2023

Store at room temperature.

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terrasil Diabetics Ulcer and Sore Relief - FDA Drug Approval Details