Label: THERAWORX JOINT RELIEF ROLL ON- frankincense liquid

  • Category: HUMAN OTC 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 August 31, 2023

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  • Drug Facts

  • Active Ingredient

    Olibanum 8X 0.05% HPUS

    The letters H.P.U.S. indicate that the components in this product are officially monographed in the homeopathic pharmacopoeia of the United State.

    Purpose

    Anti Inflammatory

  • Uses

    • relieves joint discomfort
    • increase range of motion
    • improves daily function
  • Warnings

    For external use only.If eye contact occurs, rinse thoroughly with water.

    When using this product

    • avoid eye contact
    • store between 32°F and 120°F
    • use only as directed
    • not for ingestion

    Stop use and ask a doctor if

    unintended effects occur.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • roll a thin layer to each affected area and allow to air dry
    • if applicable put on compression
    • repeat
    • use as needed
  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Calcium Carbonate, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol Acetate, Vitex Agnus- Castus Extract, Xanthan Gum, Yeast Extract, Yucca shidigera Extract

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    THERAWORX JOINT RELIEF ROLL ON 
    frankincense liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-027
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHASTE TREE FRUIT (UNII: 433OSF3U8A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-027-001 in 1 CARTON01/15/2023
    174 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/15/2023
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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