Label: TERRASIL WOUND CARE - allantoin 0.5%, benzethonium chloride 0.5% ointment

  • NDC Code(s): 24909-115-44
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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%

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  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - Antiseptic

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  • 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.

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  • 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.

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  • 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.

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  • Inactive Ingredients

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

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  • INGREDIENTS AND APPEARANCE
    TERRASIL WOUND CARE  
    allantoin 0.5%, benzethonium chloride 0.5% ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-115
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin 0.5 g  in 100 g
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24909-115-44 44 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 01/20/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    Name Address ID/FEI Business Operations
    Aidance Skincare & Topical Solutions, LLC 018950611 manufacture, label
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