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NDC 24909-0216-50 Terrasil Balanitis Relief 1; 1 [hp_X]/g; [hp_X]/g Details

Terrasil Balanitis Relief 1; 1 [hp_X]/g; [hp_X]/g

Terrasil Balanitis 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 SULFUR; SYMPHYTUM OFFICINALE WHOLE.

Product Information

NDC	24909-0216
Product ID	24909-216_dffc9e20-bec9-25bd-e053-2a95a90a3804
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 Balanitis Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sulfur, Symphytum Officinale
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	1; 1
Active Ingredient Units	[hp_X]/g; [hp_X]/g
Substance Name	SULFUR; SYMPHYTUM OFFICINALE 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 24909-0216-50 (24909021650)

Pricing Information	N/A
NDC Package Code	24909-216-50
Billing NDC	24909021650
Package	50 g in 1 TUBE (24909-216-50)
Marketing Start Date	2016-06-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f2736fcd-f6c3-4946-b193-6382557eaf74 Details

Active Ingredient and Purpose

Sulfur 1X HPUS - Rash Relief

Symphytum Officinale (Comfrey) 1X HPUS - Inflammatory Relief.

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

Uses

Helps relieve irritated skin at the head of the penis.

Warnings

For external use only.When using this product do not use in or near eyes. Stop use and ask a doctor if symptoms last more than 3 days, symptoms worsen, or symptoms clear up and occur again within a few days. Keep out of reach of children. If swallowed, call Poison Control or seek medical help right away.

Directions

Adults and children 2 years of age and older: Apply to affected area 2 to 3 times per day or as needed. Children under 2 years of age: Consult a doctor. Store at room temperature. May stain fabrics.

Inactive Ingredients

allantoin, beeswax (organic), bentonite (volcanic clay)*, cedarwood oil, coconut oil, cottonseed oil*, jojoba seed oil, lavender oil, magnesium oxide, silver stearate, sunflower oil*, zinc oxide ♦3X the bacteria fighting power compared to other brands - data on file. *may contain this ingredient

Questions?

401-432-7750 or www.aidance.com

Product label

INGREDIENTS AND APPEARANCE

TERRASIL BALANITIS RELIEF

sulfur, symphytum officinale ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X] in 1 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	1 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
BENTONITE (UNII: A3N5ZCN45C)
ALLANTOIN (UNII: 344S277G0Z)
COTTONSEED OIL (UNII: H3E878020N)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
COCONUT OIL (UNII: Q9L0O73W7L)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILVER OXIDE (UNII: 897WUN6G6T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ZINC OXIDE (UNII: SOI2LOH54Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24909-216-50	50 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/03/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-216)

Revised: 5/2022

Document Id: dffc9e20-bec9-25bd-e053-2a95a90a3804

Set id: f2736fcd-f6c3-4946-b193-6382557eaf74

Version: 1

Effective Time: 20220527