24909-216 terrasil Balanitis Relief Ointment

Terrasil Balanitis Relief by

Drug Labeling and Warnings

Terrasil Balanitis Relief by is a Homeopathic medication manufactured, distributed, or labeled by Aidance Skincare & Topical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TERRASIL BALANITIS RELIEF- sulfur, symphytum officinale ointment 
Aidance Skincare & Topical Solutions, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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24909-216 terrasil Balanitis Relief Ointment

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 productdo not use in or near eyes. Stop use and ask a doctor ifsymptoms 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 ♦3Xthe bacteria fighting power compared to other brands - data on file. *may contain this ingredient

Questions?

401-432-7750 or www.aidance.com

Product label

TERRASIL BALANITIS RELIEF 
sulfur, symphytum officinale ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-216-50	50 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2016	12/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/03/2016	12/29/2018

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

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

Revised: 5/2024

Document Id: 193d2b61-d40f-e559-e063-6394a90ac521

34390-5

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

Version: 2

Effective Time: 20240524

 

Aidan