Label: TERRASIL ECZEMA AND PSORIASIS- thuja occidentalis, symphytum officinale kit

  • NDC Code(s): 24909-167-99, 24909-177-85, 24909-187-28
  • 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 April 11, 2016

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  • Active Ingredient

    Thuja Occidentalis 3X HPUS, Symphytum Officinale (Comfrey) 1X HPUS

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

  • Purpose

    Thuja Occidentalis - Eczema & Psoriasis Relief / Dry Skin Relief
    Symphytum Officinale (Comfrey) - Inflammatory Relief

  • Uses

    To relieve symptoms associated with eczema, psoriasis, and severe dry, itchy and flaky skin.

  • Warnings

    For external use only

    Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult a physician.

    If pregnant or breast feeding, contact a physician prior to use.

    Keep out of reach of children.

    If swallowed, consult a physician.

  • Directions

    Severe Outbreak Ointment: Massage a small amount into affected skin. Reapply up to 4 times daily.
    Store at room temperature. May stain fabrics.

    Daily Care Cream: Massage into affected skin. Reapply up to 4 times daily. Store at room temperature.

  • Inactive Ingredients

    Severe Outbreak Ointment: Beeswax (organic), bentonite (volcanic clay), cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, zinc oxide.

    Daily Care Cream: Beeswax (organic), cotton seed oil, emulsifying wax, jojoba seed oil, kokum butter, magnesium oxide, peppermint oil, shea butter, silver oxide, sorbic acid, water, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - BOX

    ECZEMA & PSORIASIS
    2 Tube System

    All Natural

    terrasil

    1 > Daily Care Cream

    2 > Severe Outbreak Ointment

    Patented Medical Technology

    3X TRIPLE ACTION FORMULA - Fast & Effective Relief

    Box

  • INGREDIENTS AND APPEARANCE
    TERRASIL ECZEMA AND PSORIASIS 
    thuja occidentalis, symphytum officinale kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-167
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-167-991 in 1 PACKAGE, COMBINATION04/20/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 85 g
    Part 21 TUBE 28 g
    Part 1 of 2
    TERRASIL ECZEMA AND PSORIASIS DAILY CARE 
    thuja occidentalis, symphytum officinale cream
    Product Information
    Item Code (Source)NDC:24909-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [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
    WHITE WAX (UNII: 7G1J5DA97F)  
    COTTONSEED OIL (UNII: H3E878020N)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-177-8585 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2016
    Part 2 of 2
    TERRASIL ECZEMA AND PSORIASIS SEVERE OUTBREAK 
    thuja occidentalis, symphytum officinale ointment
    Product Information
    Item Code (Source)NDC:24909-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [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
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-187-2828 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2016
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-167) , label(24909-167)
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