Label: THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMATION- frankincense solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 26, 2021

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  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMATION 
    frankincense solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71064-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71064-0013-3101 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/11/2020
    Labeler - Relion Manufacturing (085629765)
    Registrant - Avadim Technologies Inc. (041443877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Relion Manufacturing085629765manufacture(71064-0013)