Label: TERRASIL SKIN REPAIR MAXIMUM STRENGTH- calendula, symphytum officinale, thuja occidentalis ointment

  • NDC Code(s): 24909-181-14, 24909-181-50
  • 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 February 26, 2019

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  • Active Ingredients and Purpose

    Calendula 1X HPUS - Healing Agent, Symphytum Officinale (Comfrey) lX HPUS - Inflammatory Relief, Thuja Occidentalis 6X HPUS - Skin Eruption Relief.

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

  • PURPOSE

  • Uses

    • Topical antiseptic helps decrease the risk of skin infection. Helps protect skin and supports healing of minor burns, skin lesions, sores, blisters, cracked or damaged skin and lips.
    • Also helps protect from the drying effects of wind and cold weather.
  • 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.

    Do not use 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Wash and dry affected skin. Apply a thin layer of Terrasil. Repeat procedure 2 to 3 times daily until skin improves. 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 contant this ingredient.

  • PRINCIPAL DISPLAY PANEL

    All Natural
    terrasil®
    ANTI-BACTERIAL
    SKIN REPAIR OINTMENT
    MAXIMUM STRENGTH
    with Activated Minerals®

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL SKIN REPAIR  MAXIMUM STRENGTH
    calendula, symphytum officinale, thuja occidentalis ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-181
    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 1 g
    COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT1 [hp_X]  in 1 g
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE6 [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)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-181-5050 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    2NDC:24909-181-1414 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-181) , label(24909-181)
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