Label: TERRASILMED ONC- allantoin ointment

  • NDC Code(s): 24909-029-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • Active Ingredient

    Allantoin 0.5%

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent, temporarily protect, and relieve cracked skin.

  • KEEP OUT OF REACH OF CHILDREN

  • 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. Consult a doctor before using on deep puncture wounds 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. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

  • Inactive Ingredients

    beeswax, MCT (coconut oil), peppermint oil, petrolatum, silver oxide, sorbic acid, stearic acid

  • Other information

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

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    TERRASILMED ONC 
    allantoin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-029
    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
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-029-5050 g in 1 TUBE; Type 0: Not a Combination Product09/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/16/2023
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-029)
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