Label: TERRASILMED INFECTION CONTROL AND PROTECTION- allantoin,benzethonium chloride ointment

  • NDC Code(s): 24909-025-50
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 25, 2023

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  • Active Ingredients                                    Purpose

    Allantoin 0.5%                                             Skin Protectant
    Benzethonium Chloride 0.1%                        First Aid Antiseptic

  • PURPOSE

  • Uses

    Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers and cracked skin. Topical antiseptic to help decrease the risk of skin infection.

  • 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.

    Do not use on deep or puncture wounds, animal bites or serious burns.

    Keep out of reach of children. If swallowed, consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Wash and dry affected skin. Apply a thin layer of product. Cover affected area with a clean bandage. Repeat procedure as directed by healthcare provider or daily until affected area improves. Store at room temperature. May stain fabrics.

  • Inactive ingredients

    Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid

  • Questions?

    401-432-7750 or www.aidance.com

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    TERRASILMED INFECTION CONTROL AND PROTECTION 
    allantoin,benzethonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SILVER STEARATE (UNII: 4H6PCL92ZN)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-025-5050 g in 1 TUBE; Type 0: Not a Combination Product05/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/08/2023
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-025)
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