Label: THERAWORX NERVE RELIEF FOAM- onion, hypericum perforatum whole, sanguinaria canadensis root aerosol, foam

  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredients

    Allium cepa 10X 0.05% HPUS

    Hypericum perforatum 10X 0.05% HPUS

    Sanguinaria canadensis 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 States.

    Purpose

    For the temporary relief of nerve pain

  • Uses

    • relieves nerve discomfort 
    • soothes aggravated nerves 
    • targets nerve receptors
  • Warnings

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

    When using this product

    • avoid eye contact
    • store between 32ºF and 120ºF
    • ues only as directed 
    • not for ingestion

    Stop use and ask a doctor if 

    unintended effects occurs.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of chidlren.

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

  • Directions

    • shake well 
    • apply 2 pumps to each affected area
    • rub in briskly until absorbed 
    • repeat and allow to air dry 
    • use as needed
  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Diazolidinyl Urea, Glycerin, Leuconostoc/ Radish Root Ferment Filtrate, Methylparaben, PEG / PPG - 4/12 Dimethicone, Propylene Glycol, Propylparaben, Tetrasodium EDTA, Tocopheryl Acetate, Yeast Extract

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    THERAWORX NERVE RELIEF FOAM 
    onion, hypericum perforatum whole, sanguinaria canadensis root aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION10 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE10 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-020-00210 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2022
    Labeler - AVADIM HOLDINGS, INC. (118512488)
    Registrant - AVADIM HOLDINGS, INC. (118512488)
    Establishment
    NameAddressID/FEIBusiness Operations
    AVADIM HOLDINGS, INC.118512488manufacture(61594-020)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!