Label: TERRASIL ITCH, RASH AND PAIN RELIEF MAXIMUM STRENGTH- allantoin, menthol ointment

  • NDC Code(s): 24909-160-14, 24909-160-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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 January 4, 2019

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  • Active Ingredients

    Allantoin 0.5%, Menthol 0.15%

  • Purpose

    Allantoin - Skin Protectant
    Menthol - Topical Anesthetic

  • Uses

    For temporary relief and protection from 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 pregnant or breast feeding, contact physician prior to use.

    Keep out of reach of children. If swallowed, consult physician.

  • Directions

    Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. Store at room temperature. May stain fabrics.

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, vegetable stearic acid (naturally sourced), zinc oxide.

    **may contain this ingredient.

  • PRINCIPAL DISPLAY PANEL 

    All Natural
    terrasil®
    ITCH, RASH & PAIN RELIEF OINTMENT
    MAXIMUM STRENGTH
    with Activated Minerals®

    Terrasil

  • INGREDIENTS AND APPEARANCE
    TERRASIL ITCH, RASH AND PAIN RELIEF MAXIMUM STRENGTH 
    allantoin, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5   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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-160-5050 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    2NDC:24909-160-1414 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-160) , label(24909-160)
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