Label: THERAWORX RELIEF FOR MUSCLE CRAMPS- magnesium sulfate, unspecified form spray

  • 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 December 12, 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 soreness
  • 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
    • apply 6–8 pumps to each impacted muscle group
    • rub in briskly until absorbed
    • repeat
    • allow to air dry
    • use as needed
  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe barbadensis Leaf Juice, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol, Yeast Extract

  • SPL UNCLASSIFIED SECTION

    Store between 32°F and 120°F

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF FOR MUSCLE CRAMPS 
    magnesium sulfate, unspecified form spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-026
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    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)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-026-001 in 1 CARTON08/02/2023
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/02/2023
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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