TERRASIL ITCH, RASH AND PAIN RELIEF MAX (ALLANTOIN, LIDOCAINE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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TERRASIL ITCH, RASH AND PAIN RELIEF MAX (ALLANTOIN, LIDOCAINE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-124-14, 24909-124-44
Set ID 36224557-ea12-441e-b11d-ef70070826f2
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART347
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  • Active Ingredients

    Allantoin 1%, Lidocaine HCL 1%

  • 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  MAX
    allantoin, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin1 g  in 100 g
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride1 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:24909-124-1414 g in 1 JAR
    2NDC:24909-124-4444 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(24909-124) , label(24909-124)
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