Label: TERRASIL WOUND CARE- allantoin 0.5%, benzethonium chloride 0.5% 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 January 20, 2012

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  • Active Ingredient

    Allantoin 0.5%

    Benzethonium Chloride 0.5%

  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - Antiseptic

  • Uses

    Temporarily protects minor cuts, scrapes, burns. Helps relieve chapped or cracked skin and lips. Helps protect from the drying effects of wind and cold weather. First aid 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

    (Organic) Beeswax, Bentonite, Simmondsia Chinensis (Jojoba) Seed Oil, Magnesium Oxide, Peppermint Oil, Sage Oil, Silver Oxide,
    Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL WOUND CARE  
    allantoin 0.5%, benzethonium chloride 0.5% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-115
    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 Chloride0.5 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)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-115-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/20/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture, label
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