Label: TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE KIT- hexylresorcinol kit

  • NDC Code(s): 24909-040-01, 24909-041-14
  • Packager: Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Active Ingredient                                  Purpose

    Hexylresorcinol 0.10%                         First Aid Antiseptic

  • PURPOSE

  • Uses

    First Aid to help protect against infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only.

    Do not usein the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Stop use and ask a doctor if the condition persists or gets worse. Do not uselonger than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage.

  • Inactive Ingredients

    beeswax, coconut oil (organic), cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, zinc oxide

  • Other information

    Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE KIT 
    hexylresorcinol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-040
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-040-011 in 1 KIT10/02/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 g
    Part 2 1 
    Part 1 of 2
    TERRASIL FIRST AID ANTISEPTIC WOUND AND BURN CARE 
    hexylresorcinol ointment
    Product Information
    Item Code (Source)NDC:24909-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N) HEXYLRESORCINOL0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COTTONSEED OIL (UNII: H3E878020N)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    PALM OIL (UNII: 5QUO05548Z)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SAGE OIL (UNII: U27K0H1H2O)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-041-1414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM003
    Part 2 of 2
    TERRASIL HOSPITAL GRADE BANDAGING 
    strip, adhesive, closure, skin
    Product Information
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceABC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/02/2023
    Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-040, 24909-041)
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