Label: TERRASIL DIABETICS ULCER AND SORE RELIEF KIT- allantoin kit

  • NDC Code(s): 24909-034-14, 24909-039-01
  • Packager: Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 20, 2024

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  • Active Ingredient                                  Purpose

    Allantoin 0.6%                                 Skin Protectant

  • PURPOSE

  • Uses

    Helps prevent, temporarily protect, and relieve chapped or cracked skin.

  • 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  
    • symptoms clear up and occur again within a few days.

    Consult a doctor before using

    • on deep or puncture wounds
    • animal bites 
    • serious burns. 

    Keep out of reach of children. If swallowed, call Poison Control or seek medical help.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Wash and dry affected skin. Apply an ample amount of ointment. Cover with a clean bandage as needed. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

  • Inactive Ingredients

    beeswax, calendula extract, coconut oil (organic), comfrey extract, cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, sunflower oil, tea tree oil, thuja extract, 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 DIABETICS ULCER AND SORE RELIEF KIT 
    allantoin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-039
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-039-011 in 1 CARTON; Type 1: Convenience Kit of Co-Package03/18/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 g
    Part 21 BOX 75 g
    Part 1 of 2
    TERRASIL DIABETICS ULCER AND SORE RELIEF 
    allantoin ointment
    Product Information
    Item Code (Source)NDC:24909-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-034-1414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM016
    Part 2 of 2
    TERRASIL DIABETICS CLEANSING BAR 
    cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic10/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/18/2024
    Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-039)
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