Label: TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, lidocaine ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 Ingredients

    Allantoin 0.5%, Lidocaine HCL 0.5%

  • Purpose

    Allantoin - Skin Protectant

    Lidocaine HCL - Topical Anesthetic

  • Uses

    For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.


  • Warnings

    For external use only. Avoid contact with eyes. Do not apply to open wounds
    or damaged skin. If symptoms persist for more than seven days, discontinue use and
    consult physician. If swallowed, consult physician. Do not bandage tightly.
    If pregnant or breast feeding,     contact physician prior to use.

    Keep out of reach of children.

    If swallowed, consult physician.

  • Directions

    Apply directly to effected area. Do not use more than four
    times per day. Store at room temperature.

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL - 44g Label

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL ITCH, RASH AND PAIN RELIEF 
    allantoin, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 g  in 100 g
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    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:24909-123-1414 g in 1 JAR
    2NDC:24909-123-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-123) , label(24909-123)
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