Label: TERRASIL COLD SORE TREATMENT MAX- allantoin, benzalkonium 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 1.0%, Benzalkonium Chloride 0.13%

  • Purpose

    Allantoin - Skin Protectant
    Benzalkonium Chloride - Cold sore / fever blister treatment; Topical Antiseptic

  • Uses

    • To treat cold sores / fever blisters.
    • To help guard against infection. 
  • Warnings

    For external use only.
    Do not use in the eyes over large areas of the body if you are allergic to any ingredient in this product longer than one week unless directed by doctor
    Stop use and ask doctor if condition persists or worsens symptoms persist for more than 7 days.
    Ask a doctor if used to treat deep or puncture wounds, animal bites or serious burns you are pregnant or nursing.
    When using this product you may feel a brief stinging sensation when you apply it. The stinging should go away in a short time.

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Adults and children 12 years or over: Wash hands before and after applying Terrasil. Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle). Early treatment ensures the best results. Rub in gently but completely. Do not use more than 3 times a day. Children under 12 years: ask a doctor. Store at room temperature.

  • Inactive Ingredients

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



  • PRINCIPAL DISPLAY PANEL - 14g Label

    Jar Label.

  • INGREDIENTS AND APPEARANCE
    TERRASIL COLD SORE TREATMENT  MAX
    allantoin, benzalkonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-108-1414 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-108) , label(24909-108)
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