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NDC 24909-0195-44 Terrasil Diabetics Ulcer and Sore Relief 1; 6 [hp_X]/44g; [hp_X]/44g Details

Terrasil Diabetics Ulcer and Sore Relief 1; 6 [hp_X]/44g; [hp_X]/44g

Terrasil Diabetics Ulcer and Sore Relief is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Aidance Skincare & Topical Solutions, LLC. The primary component is CALENDULA OFFICINALIS FLOWER; THUJA OCCIDENTALIS WHOLE.

Product Information

NDC	24909-0195
Product ID	24909-195_a5f8b88d-68a2-43b4-a9e1-1cd6ea9c1d2b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Terrasil Diabetics Ulcer and Sore Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	CALENDULA OFFICINALIS FLOWER, THUJA OCCIDENTALIS WHOLE
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1; 6
Active Ingredient Units	[hp_X]/44g; [hp_X]/44g
Substance Name	CALENDULA OFFICINALIS FLOWER; THUJA OCCIDENTALIS WHOLE
Labeler Name	Aidance Skincare & Topical Solutions, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24909-0195-44 (24909019544)

Pricing Information	N/A
NDC Package Code	24909-195-44
Billing NDC	24909019544
Package	44 g in 1 JAR (24909-195-44)
Marketing Start Date	2020-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7e8e9b1d-1654-499f-ab32-bc12ac6883de Details

Active Ingredients

Calendula 1X HPUS .......................Healing Agent

Thuja Occidentalis 6X HPUS .............Skin Eruption Relief

The letters HPUS indicate the component(s) in this product is (are) ofﬁcially monographed in the Homeopathic Pharmacopeia of the United States.

SPL UNCLASSIFIED SECTION

Uses

Helps soothe and promote healing of skin ulcers and sores.

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.

SPL UNCLASSIFIED SECTION

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. Store at room temperature. May stain fabrics.

Inactive ingredients

beeswax (organic), bentonite (volcanic clay), cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, Silver Stearate, tea tree oil, zinc oxide

Questions?: 401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL DIABETICS ULCER AND SORE RELIEF

calendula officinalis flower, thuja occidentalis whole ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-195
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 44 g
THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N)	THUJA OCCIDENTALIS WHOLE	6 [hp_X] in 44 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
BENTONITE (UNII: A3N5ZCN45C)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
TEA TREE OIL (UNII: VIF565UC2G)
ZINC OXIDE (UNII: SOI2LOH54Z)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-195-44	44 g in 1 JAR; Type 0: Not a Combination Product	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/01/2020

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-195)

Revised: 11/2020

Document Id: a5f8b88d-68a2-43b4-a9e1-1cd6ea9c1d2b

Set id: 7e8e9b1d-1654-499f-ab32-bc12ac6883de

Version: 1

Effective Time: 20201123

Search by Drug Name or NDC

NDC 24909-0195-44 Terrasil Diabetics Ulcer and Sore Relief 1; 6 [hp_X]/44g; [hp_X]/44g Details

Terrasil Diabetics Ulcer and Sore Relief 1; 6 [hp_X]/44g; [hp_X]/44g

Product Information

Package

Package Images

NDC 24909-0195-44 (24909019544)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7e8e9b1d-1654-499f-ab32-bc12ac6883de Details

Active Ingredients

SPL UNCLASSIFIED SECTION

Uses

Warnings

SPL UNCLASSIFIED SECTION

Directions

Inactive ingredients

Product label

INGREDIENTS AND APPEARANCE

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