Label: TERRASIL SKIN REPAIR- allantoin ointment

  • NDC Code(s): 24909-032-14, 24909-032-20, 24909-032-50
  • Packager: Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Active Ingredient                                 

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects minor cuts, scrapes, and burns. 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 ifcondition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Do not useon deep or puncture wounds, animal bites or serious burns. K eep 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. Bandage when appropriate. Repeat procedure 1 to 3 times daily until skin improvement or as directed by a doctor.

  • Inactive Ingredients

    beeswax, calendula extract, coconut oil (organic), 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

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  • INGREDIENTS AND APPEARANCE
    TERRASIL SKIN REPAIR 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-032-1414 g in 1 TUBE; Type 0: Not a Combination Product10/02/2023
    2NDC:24909-032-5050 g in 1 TUBE; Type 0: Not a Combination Product10/02/2023
    3NDC:24909-032-20200 g in 1 JAR; Type 0: Not a Combination Product10/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/02/2023
    Labeler - Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions018950611manufacture(24909-032)
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