Label: TERRASIL INFECTION PROTECTION WOUND CARE MAXIMUM STRENGTH (calendula, thuja occidentalis , symphytum officinale- comfrey ointment

  • NDC Code(s): 24909-169-14, 24909-169-20, 24909-169-50
  • 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 November 16, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Calendula 1X HPUS, Thuja occidentalis 6X 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

    Calendula - Healing Agent, Thuja - Skin Eruption Relief, Symphytum Officinale (Comfrey)- Inflammatory Relief

  • Uses

    Helps promote healing of cuts, scrapes and minor burns.

  • Warnings

    For external use only. When using this product, do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Consult a doctor before using on deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help

  • Directions

    Wash and dry affected skin. Apply an ample amount of ointment. Cover

    with a clean bandage. Repeat procedure 1 to 3 times daily until skin improves or as directed by a

    doctor. Store at room temperature. May stain fabrics.

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide.

     **may contain this ingredient.

  • PRINCIPAL DISPLAY PANEL - 50g Tube

    terrasil 

    INFECTION PROTECTION WOUND CARE OINTMENT MAXIMUM STRENGTH

    terrasil  max

  • INGREDIENTS AND APPEARANCE
    TERRASIL INFECTION PROTECTION WOUND CARE MAXIMUM STRENGTH 
    calendula, thuja occidentalis , symphytum officinale (comfrey) ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 50 g
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE6 [hp_X]  in 50 g
    COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G) COMFREY1 [hp_X]  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-169-1414 g in 1 TUBE; Type 0: Not a Combination Product07/01/2016
    2NDC:24909-169-5050 g in 1 TUBE; Type 0: Not a Combination Product07/01/2016
    3NDC:24909-169-20200 g in 1 TUBE; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2016
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-169) , label(24909-169)