Label: THERAWORX RELIEF FOR FOOT CRAMPS FOAM- magnesium sulfate, unspecified form 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

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  • Drug Facts

  • Active Ingredient

    Contains Magnesium Sulfate (Magnesia sulphurica) 6X 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

    Muscle Soreness Relief

  • Uses

    • prevents cramps and spasms 
    • releases muscle tightness 
    • relieves muscle sorenss
  • 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 1 pump to bottom of affected foot
    • rub in briskly until absorbed 
    • repeat 
    • allow to air dry 
    • use as needed
  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe Barbadensis Leaf Extract, Aqua (Water), Beta Glucan, Citrus Grandis (Grapefruit) Seed Extract, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Methylparaben, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Propylparaben, Tetrasodium EDTA, Tocopheryl Acetate

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF FOR FOOT CRAMPS FOAM 
    magnesium sulfate, unspecified form aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-021-00101 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(61594-021)
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