Label: TERRASIL FOOT ULCER AND SORE RELIEF- allantoin ointment

  • NDC Code(s): 24909-044-44, 24909-044-85
  • Packager: Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • Active ingredients

    Allantoin 0.6%

  • Purpose

    Skin Protectant

  • 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 or clear up and occur again within a few days. Consult a doctor before using 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 an ample amount of ointment. Cover with a clean bandage. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor. Store at room temperature. May temporarily (washable) discolor skin and fabrics in
    sunlight.

  • 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, vegetable stearic acid (naturally sourced)*, zinc oxide

    *May contain this ingredient

  • PRINCIPAL DISPLAY PANEL

    Image

  • INGREDIENTS AND APPEARANCE
    TERRASIL FOOT ULCER AND SORE RELIEF 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-044
    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
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PALM OIL (UNII: 5QUO05548Z)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COTTONSEED OIL (UNII: H3E878020N)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SAGE OIL (UNII: U27K0H1H2O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-044-4444 g in 1 JAR; Type 0: Not a Combination Product12/15/2024
    2NDC:24909-044-8585 g in 1 TUBE; Type 0: Not a Combination Product12/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/15/2024
    Labeler - Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-044) , label(24909-044)
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