Label: TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, menthol 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 July 16, 2015

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  • Active Ingredients

    Allantoin 0.5%, Menthol 0.15%

  • Purpose

    Allantoin - Skin Protectant

    Menthol - 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

    bentonite, cera alba (organic beeswax), cotton seed oil, 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, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    COTTONSEED OIL (UNII: H3E878020N)  
    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:24909-154-1414 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:24909-154-4444 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/16/2015
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-154) , label(24909-154)
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