Label: TERRASIL BED SORE AND PRESSURE SORE RELIEF- calendula officinalis flower, thuja occidentalis whole ointment

  • NDC Code(s): 24909-196-44
  • 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 19, 2020

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  • Active Ingredients

    Calendula 1X HPUS .......................Healing Agent

    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

    Helps soothe and promotes healing bed sores and pressure sores

  • 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

    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 as needed. 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 stearate, tea tree oil, zinc oxide

    Questions?: 401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL BED SORE AND PRESSURE SORE RELIEF 
    calendula officinalis flower, thuja occidentalis whole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-196
    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 44 g
    THUJA OCCIDENTALIS WHOLE (UNII: 5HBV6WCE3N) (THUJA OCCIDENTALIS WHOLE - UNII:5HBV6WCE3N) THUJA OCCIDENTALIS WHOLE6 [hp_X]  in 44 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)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-196-4444 g in 1 JAR; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/01/2020
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-196)
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