Label: TERRASIL BALANITIS RELIEF (sulfur, symphytum officinale- comfrey ointment

  • NDC Code(s): 24909-119-14, 24909-119-15, 24909-119-44, 24909-119-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated December 29, 2018

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  • 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings

    For external use only.When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if - symptoms persists for more than 3 days - symptoms worsen - symptoms clear up and occur again within a few days.

  • 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.

  • Inactive Ingredients

    allantoin, beeswax (organic), bentonite (volcanic clay), cedarwood oil, coconut oil, cotton seed oil, jojoba seed oil, lavender oil, magnesium oxide, silver oxide, stearic acid, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - 14g Tube

    All Natural
    terrasil®
    BALANITIS RELIEF

    Terrasil

  • INGREDIENTS AND APPEARANCE
    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)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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 Product06/10/2014
    2NDC:24909-119-4444 g in 1 JAR; Type 0: Not a Combination Product06/10/2014
    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)
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