Label: THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF- magnesium sulfate heptahydrate spray, metered

  • 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 muscle cramps
    • releases muscle tightness
    • reduces muscle soreness
  • Warnings

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

    When using this product

    • avoid eye contact • do not store at temperature above 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 • apply 6–8 pumps onto entire muscle group(s) or area • briskly rub in until absorbed •  use as needed • allow to air dry

  • Inactive Ingredients

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF 
    magnesium sulfate heptahydrate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE6 [hp_X]  in 210 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-004-00210 mL in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/22/2017
    Labeler - AVADIM HOLDINGS, INC (118512488)
    Registrant - AVADIM HOLDINGS, INC (118512488)
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