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

  • NDC Code(s): 24909-193-50
  • 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 November 19, 2020

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  • Active Ingredients

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

    Menthol 0.15% .........................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 physician.

  • 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 stain fabrics.

  • Inactive ingredients

    beeswax (organic), bentonite (volcanic clay), cotton seed oil, eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, Silver Stearate, zinc oxide.

    Questions?: 401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL BURN CARE AND RELIEF MAXIMUM STRENGTH 
    allantoin, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-193
    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
    WHITE WAX (UNII: 7G1J5DA97F)  
    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)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-193-5050 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 finalpart34701/15/2020
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-193)
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