Label: TERRASIL BURN CARE AND RELIEF- allantoin, menthol ointment

  • NDC Code(s): 24909-194-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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  • Active Ingredients

    Allantoin 0.5%.........................Skin Protectant

    Menthol 0.1% .........................Topical Analgesic

  • PURPOSE

  • Uses

    For temporary relief of pain and itching due to minor burns, sunburn and skin irritations.

  • 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 breastfeeding, contact physician prior to use.

    Keep out of reach of children. If swallowed, consult Poison Control.

  • KEEP OUT OF REACH OF CHILDREN

  • 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
    temporarily (washable) discolor skin and fabrics in sunlight.

  • Inactive ingredients

    beeswax, cottonseed oil, eucalyptus oil, jojoba oil, magnesium oxide, peppermint oil, silver stearate, zinc oxide.

  • Product label

    terrasil Burn Care & Relief

  • INGREDIENTS AND APPEARANCE
    TERRASIL BURN CARE AND RELIEF 
    allantoin, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-194
    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) MENTHOL0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    COTTONSEED OIL (UNII: H3E878020N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-194-5050 g in 1 TUBE; Type 0: Not a Combination Product01/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/15/2020
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-194)
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