Label: TERRASIL WOUND CARE- allantoin, benzethonium chloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 5, 2012

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  • Active Ingredient

    Allantoin 0.5%

    Benzethonium Chloride 0.1%

  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - Antiseptic

  • Uses

    • Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips.
    • Topical antiseptic to help decrease the risk of skin infection.
  • 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.

  • Directions

    Wash and dry affected skin. Apply a thin layer of Terrasil. Cover affected area with a clean bandage. Repeat procedure 2-3 times daily until skin improves. Store at room temperature.

  • Inactive Ingredients

    bentonite, cera alba (organic beeswax), magnesium oxide, peppermint oil, sage oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 14g Label

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL WOUND CARE 
    allantoin, benzethonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    BENTONITE (UNII: A3N5ZCN45C)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-117-1414 g in 1 JAR
    2NDC:24909-117-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-117) , label(24909-117)
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