Label: THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION- frankincense liquid

  • NDC Code(s): 61594-013-03, 61594-013-07
  • Packager: AVADIM HOLDINGS, INC.
  • 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 April 25, 2023

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  • Drug Facts

  • Active Ingredient

    Olibanum 8x H.P.U.S. 0.05

    The letters H.P.U.S. indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    Purpose

    Anti Inflammatory

  • Uses

    • relives joint discomfort
    • increases 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 bottle well
    • apply 2 pumps to each affected area
    • rub in briskly until absorbed
    • repeat
    • allow to air dry
    • if applicable put on compression
    • use as needed
  • Inactive Ingredients

    Aqua (Water), Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Croton Lechleri Resin Extract, Agnus Castus Berry Extract, Calcium Carbonate, Colloidal Silver, Tocopheryl Acetate, Glycerin, Allantoin, Beta Glucan, Citrus Paradisi (Grapefruit) Fruit Extract, Lauryl Glucoside, Tetrasodium EDTA, PEG/PPG-4/12 Dimethicone, Methylparaben, propylparaben, Yucca Schidigera, Alcohol, Parfum (Fragrance)

  • Package Labeling:

    Bottle

  • Package Labeling:101ml

    Box

  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF JOINT DISCOMFORT AND INFLAMMATION 
    frankincense liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE8 [hp_X]  in 210 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SILVER (UNII: 3M4G523W1G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-013-07210 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2020
    2NDC:61594-013-03101 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 homeopathic01/01/2019
    Labeler - AVADIM HOLDINGS, INC. (118512488)
    Establishment
    NameAddressID/FEIBusiness Operations
    AVADIM HOLDINGS, INC.118512488manufacture(61594-013)
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