TERRASIL BALANITIS RELIEF- sulfur, symphytum officinale (comfrey) 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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24909-119 terrasil Balanitis Relief Ointment

Active Ingredient

Sulfur 1X HPUS
Symphytum Officinale (Comfrey) 1X HPUS

Purpose

Sulfur - Rash Relief
Symphytum Officinale - Inflammatory Relief

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 temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

allantoin, beeswax, cedarwood oil, cottonseed oil, jojoba oil, lavender oil, magnesium oxide, MCT Oil, silver stearate, zinc oxide.

PRINCIPAL DISPLAY PANEL - 14g & 50g Tubes

terrasil Balanitis Relief 14g Tubeterrasil Balanitis Relief 50g Tube

TERRASIL BALANITIS RELIEF 
sulfur, symphytum officinale (comfrey) ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]  in 1 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE1 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SILVER STEARATE (UNII: 4H6PCL92ZN)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-119-1414 g in 1 JAR; Type 0: Not a Combination Product06/10/201406/01/2017
2NDC:24909-119-4444 g in 1 JAR; Type 0: Not a Combination Product06/10/201406/01/2017
3NDC:24909-119-1514 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
4NDC:24909-119-5050 g in 1 TUBE; Type 0: Not a Combination Product12/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/10/2014
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-119) , label(24909-119)

Revised: 5/2024
Document Id: 193cd69e-85e5-ef43-e063-6394a90a3759
Set id: 16c243e0-dec4-4643-949f-48dfd6bc5c08
Version: 3
Effective Time: 20240524
 
Aidance Skincare & Topical Solutions, LLC