Label: TERRASIL COLD SORE TREATMENT MAX- allantoin 1.0%, lidocaine 1.0% 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 February 1, 2012

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  • Active Ingredient

    Allantoin 1.0%, Lidocaine 1.0%

  • Purpose

    Allantoin - Skin Protectant
    Lidocaine - Topical Anesthetic

  • Uses

    Treats fever blisters and cold sores on the face or lips.
    For the temporary relief of pain and itching.
    Relieves dryness and softens cold sores and fever blisters.
    Softens crusts (scabs) which may be associated with cold sores and fever blisters.

  • Warnings

    For external use only. Do not use in or near the eyes. Avoid applying directly inside your mouth. Do not share this product with anyone. This may spread infection. Stop use and ask a doctor if: your cold sore gets worse or the cold sore is not healed within 10 days.

    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. Use 3-5 times a day until healed. Children under 12 years: ask a doctor. Store at room temperature.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Jar Label.

  • INGREDIENTS AND APPEARANCE
    TERRASIL COLD SORE TREATMENT   MAX
    allantoin 1.0%, lidocaine 1.0% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin1 g  in 100 g
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine1 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:24909-110-1414 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture, label
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