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

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 May 24, 2024

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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.

  • 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

    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

  • 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)  
    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)
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