Label: TERRASILMED BURN CARE- allantoin,menthol ointment

  • NDC Code(s): 24909-027-50
  • 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
    Menthol 0.15%                                      Topical Analgesic

  • PURPOSE

  • Uses

    Helps protect skin and provide temporary relief of pain and itching due to minor burns, sunburn, and skin irritations.

  • Warnings

    For external use only

    When using this product, do not get into eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days discontinue use and consult physician.

    If pregnant or breastfeeding, contact physician prior to use.

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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged skin. 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 BURN CARE 
    allantoin,menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 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:24909-027-5050 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 finalpart34805/08/2023
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-027)
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