Label: TERRASIL SKIN REPAIR MAX- allantoin, benzethonium chloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 5, 2012

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  • Active Ingredients

    Allantoin 1%

    Benzethonium Chloride 0.2%

  • Purpose

    Allantoin - Skin Protectant

    Benzethonium Chloride - Antiseptic

  • Uses

    • Helps protect skin and supports healing of skin lesions, ulcers, sores, blisters, cracked or damaged skin and lips.
    • Helps relieve minor skin irritation and itching due to rashes.
    • Topical antiseptic to help decrease the risk of skin infection.
  • Warnings

    For external use only.

    When using this product

    Do not get into eyes.

    Stop use and ask a doctor if

    Condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use

    On deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children.

    If swallowed, call poison control or seek medical help.

  • Directions

    Wash and dry affected skin. Apply a thin layer of Terrasil. Cover affected area with a clean bandage. Repeat procedure 2-3 times daily until skin improves. Store at room temperature.

  • Inactive Ingredients

    bentonite, cedarwood himalayan oil, cera alba (organic beeswax), magnesium oxide, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, tea tree oil, zinc oxide

  • PRINCIPAL DISPLAY PANEL - 44g Label

    Jar Label

  • INGREDIENTS AND APPEARANCE
    TERRASIL SKIN REPAIR  MAX
    allantoin, benzethonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CEDRUS DEODARA WOOD OIL (UNII: 01O086PVD0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-132-1414 g in 1 JAR
    2NDC:24909-132-4444 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34709/07/2012
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-132) , label(24909-132)
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